Sterigenics U.S., LLC

FDA Device Registration & Listing · Ontario, CA, US · Registration 2029015

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2029015
FEI Number
1000160458
Entity Name
Sterigenics U.S., LLC
City/State/Country
Ontario, CA, US
Establishment Address
687 S Wanamaker Ave, Ontario, CA 91761, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Sotera Health LLC (Owner Number: 10029425)
Owner / Operator Contact Address
2015 Spring Road, Suite 650, Oak Brook, IL 60523, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Coude UM Foley: 7016C Si Cannula Seal - 400077 Si Cautery Spatula, A-Sure (5mm) - 400160 Si Cannula Seal - 400077 Si Cautery Hook, A-Sure (5mm) - 400156 Nellcor Oximax Sensors RBC-2P REF 822-2P SET Kangaroo Feeding Tubes Kangaroo Feeding Tubes: 8888262121 Kangaroo Premature Infant PVC Feeding Set Precision™ Disposable Tissue Grinder Systems TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS DIALYSIS KIT Catheter Plug: 1600 Monoject Blood Collection Set with Tube Holder Monoject Multi-Sample Transfer Set with Holder and Safety Cap Monoject Tube Holder Monoject Transfer Device Monoject Collection Device Stelo Biosensor System DEKNATEL V-PAK (X-4948GWM10)X1 V-PAK (7-7044)X5 (X7-7044W)X5 V-PAK (X79-717M10) V-PAK (G79-717)X4 (XG79-717W)X4 V-PAK (B7-7040)X5 (B7-7040W)X5 V-PAK (69-717GW)X10 V-PAK (XH7-420GWM8)X2 V-PAK POL 2-0 KC-2 2N 30"X10 V-PAK (B7-7037)X5(XB7-7037W)X5 V-PAK (X-6473)X15 (X-6473W)X15 V-PAK DR JOHNSON V-PAK (6-774)X5 (X6-774W)X5 V-PAK (7-774)X5 (X7-774W)X5 V-PAK (XF7-774GW)X10 V-PAK ASST SUTURES X10 V-PAK (6-7027GWM10) X2 V-PAK DR RIZZONI V-PAK (H69-774)X5 (XH69-774W)X5 V-PAK (7-774)X5 V-PAK (X7-774GWM8)X2 V-PAK ASSTD SUTURES X11 V-PAK (XG7-7039)X6 (&WH)X5 V-PAK ASSTD SUTURES X8 V-PAK (X6-7037)X5 (X6-7037W)X5 V-PAK (XG69-7101GWM8)X2 V-PAK (XG69-7038GW)X10 V-PAK ASSTD SUTURES X 40 V-PAK (XB79-774GW)X10 V-PAK (XRN-5692)X8 V-PAK (C69-723GWM8)X2 V-PAK (XG79-7027GW)X10 V-PAK(F6-7044GWM8)x2 V-PAK (B69-717)X5 (B69-717W)X5 V-PAK (F6-774)X4 (XF6-774W)X4 V-PAK (G69-717GW)X10 CABG KIT V-PAK (C6-774)X5 (XC6-774W)X5 V-PAK (X-6023)X5 (X-6023W)X5 V-PAK (XB79-7072GWM8) X2 V-PAK (XH7-774)X10 V-PAK (B7-6686) X 10 (B7-6686W) X 10 V-PACK ASSORTED SUTURE X48 V-PAK (XB7-7027M8) X2 V-PAK (79-733)X5 (79-733W)X5 V-PAK (G6-7101GW)X10 V-PAK (X-7101GWM8) X2 V-PAK (XB79-774GWM8)X2 V-PAK (X-5576A)X4 (X-5576WA)X4 V-PAK (X79-774GWM8)X2 V-PAK (79-717GW)X10 V-PAK (X-6740)X5 (X-6740W) X5 V-PAK (X6-797GWM10)X2 V-PAK (B69-774GW)X10 V-PAK (XG79-7027GW)X8 RC TIE PAK TEV X1 SLK X2 V-PAK (X69-7037GWM8)X2 X69-7037GWM4)X1 V-PAK (XRN-5787)X8 V-PAK (X-6315GWM8)X2 V-PK (B6-420GW)X10 V-PAK (XC7-7045)X5 (XC7-7045W)X5 V-PAK (X69-723GWM8)X2 V-PAK (XB79-717W)X5 (B79-7 17)X5 V-PAK (X-6489GWM8)X2 VPAK (XG69-7101GWM10)X2 V-PAK (G69-424GW)X10 V-PAK (XC7-7044GWM10)X1 V-PAK (XH6-7044GW)X10 V-PAK (XG79-420GWM8)X2 V-PAK (7-7037M8) X2 V-PAK (79-716)X5 (X79-716W)X5 V-PAK (XG6-420GWM10) X2 V-PAK (XF7-798) X 10 (XF7-798W) X 10 V-PAK (XB6-420GWM8)X2 V-PAK (XB69-7037GWM8)X2 V-PAK (G7-774)X5 V-PAK (XH79-799G)X4 (XH79-799W)X4 V-PAK (X7-7039W)X5 (X7-7039)X5 V-PAK TEV GW 2-0 KC-2 2N 30" X10 V-PAK (XH7-774)X5 (XH7-774W)X5 V-PAK XF79-7027GW X10 V-PAK (79-797)X5 (X79-797W)X5 V-PAK (X6-723GWM8)X2 V-PAK (S-894)X10 V-PAK (G7-7027)X4 (G7-7027W)X4 V-PAK (XG6-723W)X5 (G6-723)X5 V-PAK (XB79-7027GWM6) X2 V-PAK (B69-717W)X3 (B69-717)X3 V-PAK (X-6020)X5 (X-6020W)X5 V-PAK (6-7101GWM8)X2 V-PAK (F69-717) X5 (F69-717W)X5 DR LYNN-MITRAL VALVE REPAIR ARMC CANNULATION PACK V-PAK (XHP-1290GW)X10 RC TIE PAK TEV X2 SLK X2 V-PAK (X6-420W)X3 (6-420)X3 V-PAK (B7-7101GW)X10 V-PAK (B7-7037)X15 V-PAK (B69-420GW)X10 V-PAK (X7-7037W)X5 (7-7037)X5 V-PAK (H7-420)X4 (XH7-420W)X4 V-PAK (XG69-420GWM8)X2 V-PAK (X-4884)X6 V-PAK (B7-774)X5 (XB7-774W)X5 V-PAK (X79-774W)X5 (79-774)X5 V-PAK (C6-420GW)X10 V-PAK (X6-420GWM8)X2 V-PAK (XH7-6770) X 4 (XH7-6770W) X 4 V-PAK (XG79-7027GWM8)X2 V-PAK POL GW 2-0 C-2 2N 30" X10 V-PAK (X-5154)X10 V-PAK (79-799)X10 V-PAK (X-6021)X5 (X-6021W)X5 V-PAK (G7-774)X3 (XG7-774W)X3 V-PAK ASSTD SUTURE X5 V-PAK (X-6078)X5 (X-6078W)X5 V-PAK (X-6025)X5 (X-6025W)X5 VPAK (X-7080) X 4 (X-7080W) X 4 V-PAK DR HARVEY V-PAK (X-4529)X4 (4529W)X4 V-PAK (XB6-7038GW)X8 V-PAK (XG79-774GW)X10 V-PAK (B79-774GWM10)X1 V-PAK ASSTD SUTURES V-PAK B79-420 X5 XB79-420W V-PAK (X7-6803GWM7)X1 (X7-6803GWM8)X1 V-PAK (G6-774)X5 (XG6-774W)X5 V-PAK (H7-420)X5 (XH7-420W)X5 V-PAK (X79-7027GWM8) X1 V-PAK (X-6744)X4 (X-6744W)X4 V-PAK (G69-774)X5 (XG69-774W)X5 V-PAK (G7-7044)X5 (G7-7044W)X5 V-PAK (XB-5670)X4 (XB-5670W)X4 V-PAK (XG7-7080)X5 V-PAK ASSTD SUTURES X10 V-PAK (G69-7101)X5 (G69-7101W)X5 V-PAK ASSTD SUTURES X20 V-PAK (G7-774)X10 V-PAK (7-797)X5 V-PAK (7-760) X5 (7-760W) X5 V-PAK (XH7-6770) X 5 (XH7-6770w) X 5 V-PAK (B7-420)X5 (XB7-420W)X5 V-PAK (X-6802) X 7 (X-6802W) X 7 V-PAK (G7-774GW)X10 V-PAK (X-6747)X10 (GFS-10A)X1 V-PAK (H6-420GW)X10 V-PAK (X79-7101GW)X10 V-PAK (X-4967)X6 V-PAK (XB79-7027W)X5 (XB-79-7027W)X5 V-PAK (G6-7101GWM8)X2 V-PAK (X7-420GWM8)X2 V-PAK (XG69-7027)X5 (XG69-7027W)X5 VPAK (7-7027GWM8)X2 V-PAK (XG6-420GWM8)X2 V-PAK (G79-420)X5 (XG79-420W)X5 V-PAK (X-6201GWM8)X1 (X-6202M8)X1 V-PAK (X79-7027GWM8)X2 V-PAK (XG7-774GWM8)X2 V-PAK (XF-6020) X5 (XF-6020W) X5 V-PAK (X-4257GW)X10 V-PAK (G6-420)X3 (G6-420W)X3 V-PAK DR BROWN V-PAK (X-4948M10) X1 0012 PER BOX V-PAK (X-5460GWM10) X1 V-PAK (X-2914W)X3 (X-2357)X3 V-PAK (7-420)X5 (X7-420W)X5 V-PAK (G79-717) (XG79-717W)X10 VPAK (XB79-420GWM8)X2 V-PAK (X-6697GW)X10 V-PAK (X-5881)X10 (X-5881W)X10 V-PAK (XG6-7037GW)X10 V-PAK (X79-414GWM8)x1 VPAK(XG7-7080GWM8)X2 V-PAK (XB7-797W)X5 B7-797X5) V-PAK (XB7-798)X15 V-PAK (X-6439)X12 V-PAK (7-420)X5 V-PAK(X-5576B)X4 (X-5576WB)X4 V-PAK (G7-420GW)X10 LACERATION KIT Trocar Catheter Thoracic Catheters Locking Syringe RegenMed Marrowminer Argyle Luki Tube Specimen Collection Device Ultra Ultra Surgical Gown Central venous catheter tray PORT ACCESS KIT CENTRAL LINE KIT VENOUS ACCESS KIT Dover Silicone Elastomer Coated Latex Foley Catheter SP Camera Instrument Sheath - 430020 SP1098 Entry Guide - 430022 SP Drape - 430013 SP Instrument Sheath - 430012 SP Monopolar Scissors Tip - 430035 General purpose dental tray EXTENSION LINES PELVIC EXAM KIT SureForm™ 60 (Stapler 60) Reload (White) - 48360W SureForm™ 60 (Stapler 60) Reload (Black) - 48360T SureForm™ 60 (Stapler 60) Reload (Blue) - 48360B SureForm™ 60 (Stapler 60) Instrument - 480460 SureForm™ 60 (Stapler 60) Reload (Green) - 48360G ClosureFast Catheter, 6FR, 60cm Sterile, 8cm Valve Adapter Argyle Penrose Tubing SuperClip Accessories, Catheter Peritoneal Lavage drainage needle/catheter "Prelude SNAP 165 Valved Splittable Sheath Introducer iprism clip D.O.R.C. Scleral depressor, reusable Radiology-diagnostic kit ARTHROGRAM KIT Nerve block tray TDL111 TDL101 TDL105 TDL102 TDL103 TDL104 TDL112 NERVE BLOCK KIT SPINAL KIT UNIVERSAL BLOCK KIT SINGLE SHOT KIT PAIN KIT TDL107 Lumbar Puncture Tray Arthrogram Tray Myelogram Tray TDL106 TDL108 TDL142 TDLC207 TDLU206 TDL139 TDLC203 TDLU212 TDL145 TDLC219 TDL133 TDLC220 TDL132 TDLC208 TDLU217 TDL134 TDL135 TDLS203 TDLC218 TDLC204 TDLC205 TDL140 TDLU233 TDLC201 TDL141 TDLC206 TDLS204 TDLU213 Blood specimen collection kit (excludes hiv testing) BLOOD CULTURE KIT BLOOD DRAW KIT Monoject Luer-Lock Collection Set Monoject Blood Collection Set with Tube Holder Monoject Blood Collection Assembly Monoject Blood Collection/Infusion Set Dover 100% Silicone Foley Catheter TEMPERATURE SENSOR Parallax T-Grip Access Needle Autologous Platelet Concentrator Fluid Transfer Device (FTD) Access Tool, Filler Placement Stylet nContact Cannula Caps-Lock Ultra Access Tool, Filler Placement Set VertecoR MidLine Osteotome 3 Ad-Tech Cannulas Cannula Surgical General and Plastic Surgery Cassi 2 Needle MEDTRONIC Facet Screw Instruments Bone Plug And Obturator ACL Disposable Kit Facet Screw Insruments 2-CAN Integra; Jarit; MicroFrance; Miltex; Padgett; Xomed Topaz EPF Cannula System Repris Bladder Injector (1017) MCS+,TPE,225 ML BOWL,LN 980 MCS+,TPE,125 ML BOWL,LN 981 Xi Conductive Reducer - 470381 Xi Reducer (12-8mm), (470381-04, 05, 06, 07, 08, 09) Xi Ports Seal (12mm & Stapler), (470380-04, 05, 06, 07) Si Stapler Sheath - 410370 Xi Stapler 45 Reload (Blue) - 48645B Xi Seal (12mm & Stapler) - 470380 12 mm & Stapler Cannula Seal - 470380 Xi Stapler 45 Reload (White) - 48645W Xi Stapler 45 Reload (Green) - 48445G Dover 100% Silicone Foley Catheter Salem Sump Silicone Dual Lumen Stomach Tube Temp Sensor Urine Meter: UM40018 Temp Sensor Urine Meter: UM40016 Dover Foley Catheter with Temperature Sensor Urinemeters ASSY,FENESTRATED BIPOLAR FORCEPS,SINGLE SITE,6-PAK (PN 428093-13) Xi Single Site Fenestrated Bipolar Forceps - 478093 Dover 100% Silicone Foley Catheter Si Harmonic ACE Insert - 400272 TAL101 TAL103 TAN101 TAL102 TAN103 TAN102 TDLS230 TAL901 TDLS205 TAL151 TALO207 TALO206 PLS BAG W/VAC SAMP & NACL SPIK Xi Vessel Sealer - 480422 Yankauer: 8888504001 TOUCH-TROL Kits and singles: 141901 TOUCH-TROL Kits and singles: 140982 Yankauer: 8888505123 TOUCH-TROL Kits and singles: 140988 Cardinal Yankauer: K61 Cardinal Medi-Vac: KEX61 Yankauer: 8888505032 Cardinal Yankauer: K87 Cardinal Yankauer: K62 Cardinal Yankauer: K60 Yankauer: 8888501007 TOUCH-TROL Kits and singles: 141900 Yankauer: 8888850131 TOUCH-TROL Kits and singles: 141906 Yankauer Suction Set: 8888501411 Yankauer Suction Set: 8888501742 Yankauer: 8888502005 Cardinal Medi-Vac: KEX61V TOUCH-TROL Kits and singles: 141908 Yankauer: 8888505040 Yankauer Suction Set: 8888501775 TOUCH-TROL Kits and singles: 141902 Yankauer Suction Set: 8888501429 Yankauer: 8888501023 TOUCH-TROL Kits and singles: 141904 Yankauer: 8888505115 Cardinal Yankauer: K86 Yankauer: 8888505024 TOUCH-TROL Kits and singles: 140980 TOUCH-TROL Kits and singles: 141903 Yankauer: 8888505016 Cardinal Yankauer: K86V Yankauer Suction Set: 8888501635 Yankauer: 8888501015 Yankauer Suction Set: 8888501619 Cardinal Yankauer: K61V Cardinal Medi-Vac: KEX60 Cardinal Yankauer: K87V Curity Infant Lumbar Puncture Tray with Safety Components Curity Adult Lumbar Puncture Tray with Safety Components Curity Pediatric Lumbar Puncture Tray with Safety Components Salem Sump Silicone Dual Lumen Stomach Tube PVC Feeding Tube: 461008 PVC Feeding Tube: 460406 PVC Feeding Tube: 460711 PVC Feeding Tube: 460802 PVC Feeding Tube: 460604 PVC Feeding Tube: 461206 PVC Feeding Tube: 460208 Xi 8mm Synchroseal - 480440 CIRCUMCISION KIT Nellcor Oxisensor II Nellcor Oximax Sensors SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM Xi Single Site Bipolar Maryland - 478080 Xi Single-Site Cannula Seal - 478161 Xi Single-Site Port - 478065 Catheter and Tip, Suction- Invuity Agilux Handheld Illuminator (H2I) Eigr Saber Waveguide, 12Fr Argyle Surgical Aspirator Tip Ortho Repositional Chest Tube Safe-T-Vac Water Tray: 10182 Safe-T-Vac Water Tray: 10142 Straight Connector: 33000 Poole Tube: 8888509737 Safe-T-Vac Saline Tray: 12191 SAFE-T-VAC: 31279 SAFE-T-VAC: 37724 Safe-T-Vac Water Tray: 10062 SAFE-T-VAC: 36626 Safe-T-Vac Saline Tray: 12142 Straight Connector: 33400 SAFE-T-VAC: 31479 SAFE-T-VAC: 31445 SAFE-T-VAC: 37224 SAFE-T-VAC: 36826 SAFE-T-VAC: 31879 Safe-T-Vac Saline Tray: 12153 Safe-T-Vac Water Tray: 10082 SAFE-T-VAC: 37424 SAFE-T-VAC: 31800 SAFE-T-VAC: 30877 Poole Tube: 8888509703 SAFE-T-VAC: 35402 SAFE-T-VAC: 31079 SAFE-T-VAC: 31044 SAFE-T-VAC: 31644 Yankauer Suction: 8888505172 Suction Instrumnet: 166025 SAFE-T-VAC: 37024 SAFE-T-VAC: 30820 SAFE-T-VAC: 30677 SAFE-T-VAC: 31200 SAFE-T-VAC: 30520 SAFE-T-VAC: 31020 SAFE-T-VAC: 31600 SAFE-T-VAC: 31420 SAFE-T-VAC: 31620 SAFE-T-VAC: 31244 Poole Tube: 88888509745 Safe-T-Vac Saline Tray: 12102 Standard Tip Yank: 41014 SAFE-T-VAC: 30888 Safe-T-Vac Saline Tray: 12182 Safe-T-Vac Saline Tray: 12062 SAFE-T-VAC: 30579 Straight Connector: 33425 SAFE-T-VAC: 31077 Suction Instrumnet: 166024 Suction Instrumnet: 166035 SAFE-T-VAC: 31400 SAFE-T-VAC: 31679 Straight Connector: 33800 SAFE-T-VAC: 36524 SAFE-T-VAC: 30688 Standard Tip Yank: 40614 Safe-T-Vac Water Tray: 10102 SAFE-T-VAC: 31820 Safe-T-Vac Saline Tray: 12082 Safe-T-Vac Water Tray: 10122 SAFE-T-VAC: 31444 Suction Instrumnet: 166031 Bulb Yank: 42614 SAFE-T-VAC: 30620 SAFE-T-VAC: 31000 SAFE-T-VAC: 37524 SAFE-T-VAC: 30500 Yankauer Suction: 8888505164 Suction Instrumnet: 166026 Suction Instrumnet: 166030 SAFE-T-VAC: 31220 Orthopedic Suction Set MEDICAL DEVICES INTERNATIONAL (MDI)- Drainage Bags Urinary drainage collection kit, for indwelling catheter P400 Premium Urine Meter: P4P14SD P400 Premium Urine Meter: P4P18XTS P400 Premium Urine Meter: P4P18CSDK P400 Premium Urine Meter: P4P18SD France prc Advantage: FPP14UL P400 Premium Urine Meter: P4P16XTS Add-A-Foley: 6175 P400 Premium Urine Meter: P4P16ts ULTRAMER Foley Tray Latex Cath: 6166LL France prc Advantage: FPP20UL ULTRAMER Foley Tray Latex Cath: 6164LL France prc Advantage: FPP18UL P400 Premium Urine Meter: P4P18XTSD P400 Premium Urine Meter: P4P18ULP P400 Premium Urine Meter: P4P14TSD P400 Premium Urine Meter: P4P14XSD Catch Kit: 5204 P400 Premium Urine Meter: P4P16SD P400 Premium Urine Meter: P4P16ULP France prc Advantage: FPP16UL P400 Premium Urine Meter: P4P14ULD P400 Premium Urine Meter: P4P18XSD Add-A-Foley: 6175MF P400 Premium Urine Meter: P4PAD France prc Advantage: FPP12UL P400 Premium Urine Meter: P4P16CSDK P400 Premium Urine Meter: P4P18CSD P400 Premium Urine Meter: P4P16XCSDK Add-A-Foley: 6256 Add-A-Foley: 6176LL P400 Premium Urine Meter: P4P16XSD Catch Kit: 5205 P400 Premium Urine Meter: P4P16ULD P400 Premium Urine Meter: P4P18ULD P400 Premium Urine Meter: P4P16TSD P400 Premium Urine Meter: P4P16XTSD P400 Premium Urine Meter: P4P16CSD ULTRAMER Foley Tray Latex Cath: 6165LL P400 Premium Urine Meter: P4P18TS P400 Premium Urine Meter: P4P18TSD P400 Premium Urine Meter: P4P18XCSDK Stapler Reload SureForm™ 45 (Blue) - 48245B SureForm™ 45 (Stapler 45) Curved-Tip Instrument - 480545 Merit Convenience Kits Single use instrument tray Navilyst Medical Convenience Kit K17 Interventional Kit K11 Pressure Monitoring Kit K09 Manifold Kit Kits VASCULAR CATH INSERTION KIT SP1098 Entry Guide - 430022 da Vinci Xi Instrument Arm Drape Instrument Arm Drape Xi Instrument Arm Drape - 470015 Xi Column Drape - 470341 Argyle CPAP Nasal Cannula with Bonnet Argyle CPAP Nasal Cannula Argon Angiography Drape OR Towel, Drapes Column Drape KP11827/250 IS4200 Arm 4 Proximal Drape - 470473 Xi Column Drape - 470341 IF1000 Vision Probe Bag - 490127 Dover 100% Silicone Foley Catheter Ultramer U/M Foley Tray: 8944 Ultramer U/M Foley Tray: 7008IC8942MF Ultramer U/M Foley Tray: 2018 Urine Meter: 8000 Urine Meter: 2008 Ultramer U/M Foley Tray: 2016 Urine Meter: 2004 Ultramer U/M Foley Tray: 6165C Ultramer U/M Foley Tray: 2020 Ultramer U/M Foley Tray: 6162 Ultramer U/M Foley Tray: 7006IC Urine Meter: 8101LL Urine Meter: 2006 Ultramer U/M Foley Tray: 8944MF Ultramer U/M Foley Tray: 2014 Urine Meter: 8122 Urine Meter: 2000 Urine Meter: 8101 Ultramer U/M Foley Tray: 8950MF Urine Meter: 2004LL Female Catheter Kit: 3411 Turkel Pneumothorax Procedure Tray with Safety Components Kangaroo Dual Port Gast: 8884715122 Kangaroo Dual Port Gast: 8884715148 Kangaroo Dual Port Gast: 8884720163 Kangaroo Dual Port Gast: 8884720189 Kangaroo Dual Port Gast: 8884720221 Kangaroo Dual Port Gast: 8884720247 Kangaroo Dual Port Gast: 8884720205 Microbore Extension Set: 60ENY Microbore Extension Set: 35ENS Kangaroo Gravity Extension Set: 60VENS Microbore Extension Set: 10ES Microbore Extension Set: 35EY Microbore Extension Set: 60ES Microbore Extension Set: 60ENS Microbore Extension Set: 10EY Microbore Extension Set: 60EY Kangaroo Gravity Extension Set: 60VENY Kangaroo Gravity Extension Set: 4VENS Microbore Extension Set: 35ENY Microbore Extension Set: 35ES ART BMC ART BMC Plus Eye tray EYE KIT AMS-7517CP IV START KIT Economy Foley: 7948 Intermittent Catheter Kit: 2540 Economy Foley: 7946 Burn kit without drug DOUGIE / BURN KIT SEQUESTRATION KITS CS ELITE PROCESSING KIT, 225ML CS ELITE PROCESSING KIT, 70ML BAG ASSY, WASTE, 10 LITER CS ELITE PROCESSING KIT, 125ML Dexcom G7 Continuous Glucose Monitoring System Nellcor™ Oximetry sensor products 11 guage Bone Access Needles Homer Breast Localization Needles OnPharma OnSet Cartridge Connector MiniStop Plus BackStop Plus Monoject Bone Marrow Biopsy Tray with Safety Components PERCUCUT NEEDLES, N105, N110, N115, N710, N715, N810, N815 Turkel Safety Fluid Drainage System Curity Amniocentesis Tray Disposable Needles BONE BIOPSY NEEDLE Curity Thoracentesis Trays with Safety Components Facet Screw Instruments FNA - Fine Needle Aspiration CHIBA NEEDLE MEDTRONIC Facet Screw Instruments Turkel Thoracentesis System: 566059 Turkel Thoracentesis System: 566034 Integra; Jarit; MicroFrance; Miltex; Padgett; Xomed Anesthesia Peribulbar; Retrobulbar Needles Turkel Thoracentesis System: 566075 Monoject Sternal-lliac Aspiration Needle Turkel Safety Thoracentesis Procedural Tray Monoject Basic Bone Marrow Biopsy and Aspiration Tray with Safety Components Monoject Bone Marrow Biopsy and Aspiration Tray with Safety Components Monoject Basic Bone Marrow Biopsy Tray with Safety Components Monoject Bone Marrow Biopsy Prepping Tray with Safety Components Monoject Bone Marrow Biopsy / Aspiration Needle Cardinal blunt fill needle with filter Temporary Sharps Holder "ShortStopGrandstand Cardinal blunt fill needle wwithout filter BD Luer Accessories Kangaroo Milk Straw: 462000E Kangaroo Milk Straw: 461000E Kangaroo Milk Straw: 464000E LUNA-100 Custom MedLabel Pack - Pack Name:San Pedro Universal Pack 1 Revision 0 Label or tag, sterile BTM217/50 BWT507/50 11166/20 17120/25 18880/20 RBL001/100 Key Surgical® Sterile Labels STL001/10 LTRED/50 11170/20 SVL002/100 LBL001/100 BNIML01/50 LTYELLOW/50 BTR230/50 PWL133/50 Labels, West Penn Package Name: Minor Plastic PBDS Pack Medication Labels, Parkview Hospital 5-Large w/ 10730 Revision 1 Labels, Reading Neuro Package Name: Med Labels - Neuro Custom MedLabel Pack - Pack Name:Upper Chesapeake Medical Center Revision 0 Custom MedLabel Pack - Pack Name:X-RAY LABELS Revision 0 Custom MedLabel Pack - Pack Name:SORS-SPC-105 Revision 0 Medication Labels,Package Name: Ortho/Total Joints Revision 2 Labels, Seattle Radiologists Package Name: Special Procedures Revision 1 Med Labels, Univ. of Mich. 1-Lg, 1-Xlg, 1-Sm, 1 Tally Sheet w/ 11735 & ruler Revision 2 Labels, UPMC St. Margarets Package Name: Eye medications Custom MedLabel Pack - Pack Name:Eye Labels 2 SM Custom MedLabel Pack - Pack Name:General Label Pack Custom MedLabel Pack - Pack Name:Ambulatory Surgery Pack Revision 0 Custom MedLabel Pack - Pack Name:Pain Management Labels Revision 5 Med Labels, Univ. of Mich 5-Lg & 1-Xlg, 1 Tally Sheet w/ 11730 Revision 3 Labels South Pointe Package Name: PAIN MEDICATIONS Custom MedLabel Pack - Pack Name:EP Lab Colored Blank Labels Revision 1 Custom MedLabel Pack - Pack Name:surgery1 Custom MedLabel Pack - Pack Name:WESTMEAD MODULE 3 Medication Labels, ICU Medical 2-small, 1-Xlarge sheet w/ 10730 DOUBLE POLY BAGGED Labels, Reading Plastics Package Name: Med- Labels- Plastics Custom MedLabel Pack - 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Ctr. 1-Small Labels, West Penn Package Name: vascular Custom MedLabel Pack - Pack Name:SORS-SPC-56 Revision 0 Custom MedLabel Pack - Pack Name:Riverview Cath Lab Revision 3 Custom MedLabel Pack - Pack Name:NHP pacer pack Revision 0 Custom MedLabel Pack - Pack Name:Surgery Pack Revision 1 Custom MedLabel Pack - Pack Name:Pacemaker Tray #BHSJ030-02 Custom MedLabel Pack - Pack Name:Ophthalmology Pack Revision 2 Medication Labels, Community Hospital North 1-Small w/ 10415 Medication Labels, Package Name: Orthop Revision 2 Custom MedLabel Pack - Pack Name:Revised Eye Label Pack Custom MedLabel Pack - Pack Name:Heart Service Custom MedLabel Pack - Pack Name:Mediation Labels Revision 0 Medication Labels, Package Name: Ortho Pack Custom MedLabel Pack - Pack Name:SORS-SPC-66 Revision 0 Custom MedLabel Pack - Pack Name:Pain clinic labels Revision 1 Custom MedLabel Pack - Pack Name:General Labels Revision 2 Custom MedLabel Pack - Pack Name:IR / NEURO LABEL PACK Revision 0 Custom MedLabel Pack - Pack Name:GYN Leep/Laser Revision 3 Custom MedLabel Pack - Pack Name:Labels Revision 2 Custom MedLabel Pack - Pack Name:Pain Labels Custom MedLabel Pack - Pack Name:Dr. Bilofsky Revision 2 Labels, Univ. of Michigan 3-Large Revision 2 Custom MedLabel Pack - Pack Name:THRDenton- Urology Labels, Reading Package Name: GU/Cysto Revision 1 Custom MedLabel Pack - Pack Name:Firelands Regional Med Center - Blank Revision 0 Med Labels, Univ. of Mich Revision 6 Custom MedLabel Pack - Pack Name:VITRECTOMY PACK - STERILE Revision 2 Medication Labels, Univ. of Michigan 1-Large, 4-Xlg, 1 Tally Sheet w/ 10730 Revision 2 Med Labels, West Penn 4-Lg w/ 10735 Med Labels, Reading Heart Center 1-small, 1-large Revision 1 Custom MedLabel Pack - Pack Name:THRDenton- Dr. Herman Med Labels- Jupiter Outpatient Surgery Center Revision 1 Custom MedLabel Pack - Pack Name:Angio Pack Revision 2 Custom MedLabel Pack - Pack Name:General Labels Revision 1 Custom MedLabel Pack - Pack Name:Tampa Bay Custom MedLabel Pack - Pack Name:Baptist Jacksonville Radiology Revision 1 Medication Labels, Package Name: Intrathecal Services Revision 2 Custom MedLabel Pack - Pack Name:Banner Desert Medical Center CVOR Revision 0 Custom Medlabel Pack - Pack Name:AAA Stents Custom MedLabel Pack - Pack Name:BIOPSY LABEL PACK Revision 1 Custom MedLabel Pack - Pack Name:Phaco Labels - Sterile Revision 3 Custom MedLabel Pack - Pack Name:EYE LABELS Revision 0 Custom MedLabel Pack - Pack Name:PILOT KIT 2 Revision 3 Custom MedLabel Pack - Pack Name:Labels Revision 1 Custom MedLabel Pack - Pack Name:Procedure Center General Labels Revision 0 Custom MedLabel Pack - Pack Name:Medication Labels Revision 0 Custom MedLabel Pack - Pack Name:Angio/Cath Lab Tray BHSJ001-06 Revision 2 Custom MedLabel Pack - Pack Name:Torrance Sterile Labels Revision 4 Labels, West Penn Package Name: GU (Barbara) Custom MedLabel Pack - Pack Name:Radiology Medication Labels, Parkview Hosp 5-Large sheets w/ 10730 Custom MedLabel Pack - Pack Name:Eye Labels Revision 0 Custom Medlabel Pack - Pack Name:Rapides Regional Medical Center 1-Med, 2-Xlg Custom MedLabel Pack - Pack Name:Ultrasound Dept. 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Hoodriver Package Name: Surgery Labels, Emory Clinic Package Name: AMYS Pack II Revision 1 Labels, West Penn Package Name: Podiatry/ Orthopedics pack Labels, West Penn Package Name: Panendoscopy Labels Custom MedLabel Pack - Pack Name:Injection Labels Custom MedLabel Pack - Pack Name:Ortho/Plastics 3 LG w/ ruler & marker Revision 1 Custom MedLabel Pack - Pack Name:Cardiac Pack Custom MedLabel Pack - Pack Name:Mammo Pack Revision 1 Med Labels, Dallas VA 4-Large w/ 10730 Custom MedLabel Pack - Pack Name:Greater Southern Area Health Services Revision 0 Custom MedLabel Pack - Pack Name:Banner Thunderbird Pack 3 Revision 0 Custom MedLabel Pack - Pack Name:PEDS/ENT 7 LG w/ruler &marker Revision 1 Custom MedLabel Pack - Pack Name:GALLBLADDER/INFUSION LABELS Revision 2 Medication Labels, Henry Ford 6-lg w/ 10730 & ruler Labels, AGH Hospital Package Name: Eye Medication Labels Custom MedLabel Pack - Pack Name:General Pack Revision 5 Custom MedLabel Pack - Pack Name:Interventional Sticker Pack Labels, West Penn Package Name: Burn Packs (Barbara) Custom MedLabel Pack - Pack Name:Willis – Knighton Medical Center Revision 0 Custom MedLabel Pack - Pack Name:Banner Good Samaritan Revision 1 Labels, Regional Medical Package Name: General Surgery Labels II Medication Labels, Package Name: Endo Vascular Revision 2 Standard Medication Labels. 1-Small sheet, 2- Large Sheets w/ 10730 Custom MedLabel Pack - Pack Name:General Labels Revision 0 Medication Labels, Univ. of Michigan Health Sys. 1 lg perm, 1 lg ez,, 4 sm, w/ 10730 Revision 6 Custom MedLabel Pack - Pack Name:Sterile Labels Medication Labels, Package Name: ENT/GYN Revision 5 Labels, UPMC Package Name: Vascular Revision 3 Custom MedLabel Pack - Pack Name:Vascular Pack Custom MedLabel Pack - Pack Name:Surgery Labels Custom MedLabel Pack - Pack Name:THRDenton-Thoracotomy Custom MedLabel Pack - Pack Name:NorthCrest Medical Center - Sterile Revision 0 Custom MedLabel Pack - Pack Name:Sterile Label Pack Revision 0 Custom MedLabel Pack - Pack Name:GGG 6 LG w/ ruler & marker Revision 1 Custom MedLabel Pack - Pack Name:USCD/Cath Revision 1 Medication Labels, Henry Ford 3-lg w/ 10730 & ruler Custom MedLabel Pack - Pack Name:Marker, Ruler & Labels Revision 4 Medication Labels 1-Large w/ 10730 Revision 1 Labels, West Penn Package Name: Vitrectomy & Scleral Buckle PBDS Revision 1 Custom MedLabel Pack - Pack Name:Major Lables-Munroe Regional CVOR Labels, Emory Clinic Orthopedic Labels, West Penn Package Name: CABG 4.67Custom MedLabel Pack - Pack Name:MEDICATION LABELS Revision 2 Medication Label Custom MedLabel Pack - Pack Name:Surgicare Med Labels Revision 0 Medication Labels, Parkview Health 1-Sml, 1-Lg,2-Xlg w/ 10735 & ruler Labels AGH Hospital Package Name: Surgicenter Revision 1 Labels, West Penn Package Name: Cataract PBDS Pack Medication Labels, Package Name: Gen/Uro Revision 2 Custom MedLabel Pack - Pack Name:Box Butte Custom Labels Revision 0 Custom MedLabel Pack - Pack Name:General Revision 0 Labels, Univ of Mich Revision 3 1 SM- 5 LG W/10415 Med Labels, Univ. of Mich 3-Lg & 1-Xlg, 1 Tally Sheet w/11730 Revision 8 Custom MedLabel Pack - Pack Name:MGH - Sonohysterograms Custom MedLabel Pack Package name: OSUM025 VIR SPEC PROC Revision 3 Custom MedLabel Pack - Pack Name:SORS-SPC-115 Medication Labels, O & M 5-Large, 1-Exta Large w/ 10730 Custom MedLabel Pack - Pack Name:EP Medication Labels Custom MedLabel Pack - Pack Name:ENT Labels Med Labels, Reading Heart Center Revision 2 Custom MedLabel Pack - Pack Name:Ophthalmology Pack Revision 4 Custom MedLabel Pack - Pack Name:THR Ortho Flower Mound Revision 0 Labels, Stillwater Package Name: Surgery Labels Revision 3 Custom MedLabel Pack - Pack Name:Gyne Pack Revision 2 Custom MedLabel Pack - Pack Name: Labels Revision 3 Med Labels, PHS 2-Large w/ 11730 Custom MedLabel Pack - Pack Name:Eye Procedure Labels Revision 1 Custom MedLabel Pack - Pack Name:UCLA Radiology Custom Labels Revision 1 Custom MedLabel Pack - Pack Name: Radiology Labels 2 LG w/ruler & marker Revision 1 Custom MedLabel Pack - Pack Name:Radiology Revision 0 Custom Medication Labels Revision 2 Custom MedLabel Pack - Pack Name:General Surgery Revision 0 Custom MedLabel Pack - Pack Name:SORS-SPC-26 Revision 0 Med Labels, Univ. of Mich. 5-Lg, 1 Tally Sheet w/ 11730 Revision 3 Custom MedLabel Pack - Pack Name:THRDenton- CVOR Hearts Custom MedLabel Pack - Pack Name:Naval Health MedPack Revision 0 Med Labels, Univ. of Mich. 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Med Labels Custom MedLabel Pack - Pack Name:Outer Curve Labels Medication Labels, Shamrock 2-Extra Large w/ 10730 Shamrock Logo on pouches Custom MedLabel Pack - Pack Name:Shadyside Labels Medication Labels, Univ. of Michigan Health Sys. 1 lg perm, 1 lg ez,, 4 sm, w/ 10730 Revision 7 Medication Labels, Univ. of Michigan 1-Large, 4-Xlg, 1 Tally Sheet w/ 10730 & ruler Rev 2 Revision Custom MedLabel Pack - Pack Name:Marymount Hospital Custom MedLabel Pack - Pack Name:Holtz Staging Labels Revision 1 1 SM label w/ ruler & marker Med Labels, Univ. of Mich 3-Lg, 5-XLG, 1 Tally Sheet w/ 11730 Revision 6 Med Labels, Univ. of Mich 5-Lg & 1-Xlg, 1 Tally Sheet w/ 11730 Revision 4 Custom Med Label Pack - Pack Name:Eye Procedures Revision 0 MediChoice 2.75" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation Labels, Univ. of Michigan 3-Large Revision 3 Custom MedLabel Pack - Pack Name:Riverview Cath Lab Revision 4 Labels, Package Name: CCMH Minor Pack Labels Custom MedLabel Pack - Pack Name:Mayo Clinic - Red Wing, MN Revision 1 Labels, Reading ENT Package Name: Med Labels- ENT Labels, Reading Retinal Retinal-Vit Revision 1 Med Labels, Univ. of Mich 4-Lg & 1 Tally Sheet w/11730 Revision 9 Custom Med Label Pack - Pack Name:ONCOLOGY PACK LABELS Revision 2 Custom Medlabel Pack - Pack Name:ORHS CRANI TRAY LABELS Custom MedLabel Pack - Pack Name:General Surgery Labels Revision 2 PAL (Pen and Label) Custom MedLabel Pack - Pack Name:Prostate Biopsy Staging Labels Revision 0 Labels South Pointe Package Name: PAIN MEDICATIONS Revision 1 Custom MedLabel Pack - Pack Name:Marker, Ruler & Labels Revision 5 Labels, Univ. of Mich 2-Large, 1-Small Revision 2 Custom MedLabel Pack - Pack Name:Mercy Hospital Rolla OSC Revision 0 Custom MedLabel Pack - Pack Name:Special Procedures Labels Halyard Basics Gown Nellcor Oxisensor II Nellcor Oximax Sensors MCS+ SDP/PLP W/SALINE,LN 994 Hensler Bone Press SafeTrap ARGYLE DeLee Mucus Traps Lukens Tube SafeTrap Tissue Collector Argyle DeLee Mucus Traps: 8888257360 Argyle DeLee Mucus Traps: 8888257378 Argyle DeLee Mucus Traps: 8888257485 Argyle DeLee Mucus Traps: 8888257469 Argyle DeLee Mucus Traps: 8888257535 Argyle DeLee Mucus Traps: 8888257550 Argyle DeLee Mucus Traps: 8888257527 Argyle DeLee Mucus Traps: 8888257386 Argyle DeLee Mucus Traps: 8888257477 Bone Vac Kangaroo Epump Set Proximal Spike Kangaroo Epump Set Kangaroo Epump and Joey Burette Set AirLife Tri-Flo Suction Cath-N-Glove Kit ClosureFast Catheter, 7FR, 60cm Sterile, 7cm COI ClosureFast Catheter, 3 cm Coil, 7French, 60 cm, STE ClosureFast Catheter, 7FR,100 cm, Sterile, 7cm Xi Stapler 30 Reload (Blue) - 48630B Xi Stapler 30 Reload (Green) - 48630G Xi Stapler 30 Reload (White) - 48630W Xi Stapler 30 Reload (Gray) - 48630M Dexcom G7 15 Day Continuous Glucose Monitoring System ClosureFast Catheter, 7FR, 60cm Sterile, 7cm COI ClosureFast Catheter, 7FR,100 cm, Sterile, 7cm Monoject Tube Holder Monoject Multi-Sample Transfer Set with Holder and Safety Cap Argyle Specimen Traps Argyle Lukens Specimen Container Argyle Specimen Traps: 3583MST7000 Bronchitrac Argyle Specimen Traps: 8884724000 Argyle Specimen Traps: 3583MST4000 Argyle Specimen Traps: 8884724504 Argyle Lukens Specimen Container: 8888258608 Argyle Specimen Traps: 8884724500 Catheters, Suction, Tracheobronchial Bronchitrac Closed Suction System CAM Catheter; Complete Airway Management Catheter, CAM Rescue Cath SP Monopolar Scissors Tip - 430035 SP Instrument Sheath - 430012 SP Camera Instrument Sheath - 430020 SP Drape - 430013 TWO UNIT RED CELLS SET,LN 832 Xi Harmonic ACE - 480275 DRESSING CHANGE KIT Blow Molded Bowls - 0625B-00 PLS SALINE ADAPTOR Zinnanti Smoke Evacuation Tubing Kit NST336/20 4905/25 19655/20 NST010/20 19611/25 19144/25 17763/50 19695/25 19689/20 19675/20 19662/20 19620/20 19685/20 MFT006/20 19669/05 19670/50 19639/50 17601/50 17602S/20 19632D/25 19726/20 19668/20 19630/25 19081/24 17756/50 17743/50 19615/25 NST041/20 19674/20 19683S/20 19633/20 13696/10 19621/20 19721/20 19728/20 19684/25 19616/25 19711CS/300 19619/25 19610/25 19638/20 17764/50 19729/100 NST043/20 19706/50 19682/20 19719/20 19711/300 NST033/20 19724/20 19671/20 19695/20 19618/20 19641/20 19677/20 19698/50 NST138/50 NST030/20 19613/25 19725/20 19634/25 NST040/20 19648/20 19653/20 NST045/20 19649/20 19625/50 19642/20 19692/50 SST001/50 19723/50 17766/50 19652/20 19730/20 19624/50 NST037/20 19667/20 19605C/20 19684/50 17619/25 19678/20 NST038/25 NST031/25 19690/25 19651/25 19632/20 19658/25 19657/20 19673/20 19727/20 19643/20 19686/50 MFT004/20 19718/20 17751/25 17641/50 19709/20 19733/50 NST034/25 19732/20 NST035/20 19722/20 19602S/20 19680/25 19672/50 19683W/20 19659/20 19082/24 19640/20 19629/20 17769/50 19705/20 NST038/20 19620D/20 19713/50 19637/20 NST011/10 19636/20 NST042/25 19635/20 19720/20 19736/25 19663/20 19676/20 NST039/20 19627/20 19660/25 19634/20 19716/20 19656/25 19623/20 17768/50 19646/25 19647/25 19665/20 19625/25 19645/25 17611/50 19644/20 19691/20 19717/20 19631/20 19679/20 19707/10 NST032/25 17602/50 19712/20 NST036/20 17332W/05 19664/25 19715/20 17751/50 19050/25 17762/50 NST136/25 Molded Connector Tube: 888284505 Connect Tube: 8888284745 Spike Entry Port S/A (HP-IRR) Connect Tube: 8888284703 Molded Connector Tube: 8888301630 Molded Connector Tube: 8888301645 Molded Connector Tube: 8888301622 Molded Connector Tube: 8888301713 Connector: 155659 Connect Tube: 8888284638 Connect Tube: 8888284547 Connect Tube: 8888284620 Molded Connector Tube: 8888301523 Molded Connector Tube: 8888301705 Connect Tube: 8888284604 Molded Connector Tube: 8888301739 Spike Entry Port S/A (HP-NIR) - 128402000 Molded Connector Tube: 8888301606 Molded Connector Tube: 8888301507 Molded Connector Tube: 8888301531 Connect Tube: 8888284539 Connect Tube: 8888284612 Connector: 155658 Connect Tube: 8888271007 Molded Connector Tube: 8888301509 Molded Connector Tube: 8888301515 Connect Tube: 8888284521 Connect Tube: 8888284711 Molded Connector Tube: 8888301549 Molded Connector Tube: 8888301721 Connect Tube: 8888284554 Molded Connector Tube: 8888301609 Spike Entry Port S/A (HP-IRR) - 201739000 Spike Entry Port S/A (HP-NIR) Connect Tube: 8888284737 Molded Connector Tube: 8888301614 Connect Tube: 8888284513 5-in-1 Connector RBC Glycerolization Set RBC De-Glyverol Set 325mL BMB RBC De-Glycerol/Cell Wash St Polyurethane Feeding Tube: 461355 Polyurethane Feeding Tube: 461701 Polyurethane Feeding Tube: 461438 Polyurethane Feeding Tube: 461412 Polyurethane Feeding Tube: 461800 Polyurethane Feeding Tube: 461503 Polyurethane Feeding Tube: 461042 Polyurethane Feeding Tube: 461420 LUMBAR PUNCTURE KIT Prep Tray Wet PVP-I Vaginal w/Glove 07 0010 Samco™ Bio-Tite™, 90mL, Midstream Kit with Funnel 02 0016 Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap 02 0002 Cardinal Health™ Specimen Container, 90mL/48mm, ORG Cap container, specimen, sterile Vacuette No -Additive Tubes Clikseal Portex Speciman Trap Midstream Kit (Container Specimen) Pathology Container, Snap Cap, PN 0480-1101 Pathology Container, Snap Cap, PN 0450-1101 Pathology Container, Snap Cap, PN 0450-1111 1008/100 1002/36 Pathology Container, Snap Cap, PN 0501-1101 19227/12 B0810/50 Pathology Container, Snap Cap, PN 0480-1111 B0612/100 17531/50 B1708/50 TP002/50 1060/50 1050/50 PSS001/25 TP0014/50 B2923/50 B1212/25 17511/20 1005W/25 B1706/50 MHBFK01/10 JBQ773 1004/36 17531/20 PDC001/20 KB006L/20 B1111Z/25 B1912/100 B1710/100 1055/50 B1115Z/50 B0633/50 1013/100 1007/50 1070/50 SSB001/10 17555/50 B0606/25 BCP300/100 B0652/10 TP0015/50 17511C/20 TP0016/50 TP003/200 1001R/36 1055/75 SJMC001/10 B1215/100 Catch Kit: 25000 Speciman Cup: 8889207026 Corning Cryogenic vials and accessories Speciman Collection: 2600SA Catch Kit: 22000 Speciman Collection: 2090SA 430490 430661 430489 Speciman Container: 15000 Speciman Collection: 2205SA 431422 Speciman Collection: 2040SA Catch Kit: 22015 430663 430658 Speciman Collection: 2300SA Catch Kit: 25015 Speciman Collection: 2210SA 430659 430179 352001 Speciman Cup: 8889207067 Speciman Collection: 4090SA Speciman Container: 45117 Speciman Collection: 17099 Speciman Collection: 2200SA 352045 352006 Speciman Container: 14999 Speciman Container: 14000 431421 354015 Speciman Collection: 2650SA 352003 430488 Vitronova 431386 430487 430491 431418 430656 352037 431458 430492 354013 431420 431417 431419 430662 90ORG53-1001 90ORG53-1000 90WHT53-1000 SAMCO 90mL/53mm CLK SPC LBL WT CAP ST 5000-0020 Nalgene™ Cryogenic Tube, 2 mL externally-threaded 5005-0015 Nalgene™ Specimen Cryogenic Vial, 15 mL externally-threaded 02 1090 Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, ORG Cap 90WHT53-1001 Samco™ Clicktainer™ Vial, WHT Cap, 90mL, 53mm, w/lab, temp strip, ST 90ORG53-1000 Samco™ Clicktainer™ Vial, ST, 90mL, 53mm, w/lab, ORG Cap 07 0002 Samco™ Bio-Tite™, ST, 120mL, 53mm Midstream Kit No Funnel 03 0006 Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, ORG Cap 07 0001 Samco™ Bio-Tite™, ST, 90mL, 48mm Midstream Kit with Funnel 22-2090 Samco™ Bio-Tite™ Wide Mouth, ST, 90mL, 53mm, w/lab, YEL Cap 02 1016 Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, WHT Cap 120WHT53-3000 Samco™ Clicktainer™ Vials, ST, 120mL, 53mm, Midstream Kit, no fnl 01 0001 Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, w/lab, ORG Cap CHB13905 Cardinal HealthTM Specimen Container, O/R Pouch 120mL/53mm 120ORG53-1000 Samco™ Clicktainer™ Vials, ST, 120mL, 53mm, w/lab, ORG Cap 90ORG53-1001 Samco™ Clicktainer™ Vial, ST, 90mL, 53mm, w/lab, ORG Cap, dsp box 5005-0015 Nalgene™ Specimen Cryogenic Vial, 15 mL externally-threaded 02 0002 Cardinal HealthTM Specimen Container, 90mL/48mm, ORG Cap 01 0002 120ml/53mm SPCw/LBL, WH CAP,ST 02 0039 Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, WHT Cap 120ORG53-4000 Samco™ Clicktainer™ Vials, ST, 120mL, 53mm, O/R Pouch, ORG Cap 02 1038 Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, Natural Cap 02 0214 Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap, dsp box CHB13904 Cardinal HealthTM Specimen Container 120mL/53mm 90WHT53-1000 Samco™ Clicktainer™ Vial, ST, 90mL, 53mm, w/lab, WHT Cap 120ORG53-4000 22 610 131 Fisherbrand™ 60mL, 48mm, ST, w/lab and temp strip, WHT Cap 120WHT53-4000 03 0008 Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, Green Cap 07 0020 Samco™ Bio-Tite™, 120ml, Midstream Kit, no funnel CHB13903 Cardinal HealthTM Specimen Container 90mL/53mm 5000-0050 Nalgene™ Cryogenic Tube, 5 mL externally-threaded 01 0038 Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, w/lab, NAT Cap CHB13902 Cardinal HealthTM Specimen Container 90mL/48mm 120WHT53-1000 Samco™ Clicktainer™ Vials, ST, 120mL, 53mm, w/lab, WHT Cap 07 0000 Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, no lab, ORG Cap 90WHT53-1002 Samco™ Clicktainer™ Vial, ST, 90mL, 53mm, w/temp strip, WHT Cap 90GRN53-1000 Samco™ Clicktainer™ Vial, ST, 90mL, 53mm, w/lab, GRN Cap 03 0007 Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, WHT Cap 02 0038 Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, Natural Cap 120WHT53-4000 Samco™ Clicktainer™ Vials, ST, 120mL, 53mm, O/R Pouch, WHT Cap Dexcom G7 Continuous Glucose Monitoring System Cuff Implantor Argyle Vascular Tourniquet Kit KI075/50 MCS100 24-684/20 24-706/20 25-775B/20 17119/50 19940/10 25-699/20 17645/15 KI035/50 15-274/20 19950/10 17441/24 15102/100 2110SA/25 17771/100 15202/100 SOAR Portal Tube Catalog# 304-1506 SOAR Beveled Portal Tube Catalog# 306-2209 SOAR Beveled Portal Tube Catalog# 306-2211 KI140/05 11-177 BK/20 11-182/50 12-202K/20 17640/15 19222/20 GS94-952/01 SOAR Portal Tube Catalog# 304-2205 SOAR Beveled Portal Tube Catalog# 306-1508 SP40/50 HK008/50 25-696/20 17405/48 24-708/20 17033/50 20-372S/20 18-331S/50 TOQ631 KI9384/12 TOQ634 KI160/20 17705/10 25-749/20 25-751/20 32-914/20 25-710/20 17024/20 25-107/20 KI028/20 KN2405/10 27-734R/60 KI061/50 02-447/20 SOAR Beveled Portal Tube Catalog# 306-1807 SOAR Portal Tube Catalog# 304-2607 Spineology Expandable Rake (Toothed) Catalog# 315-0027 SOAR Portal Tube Catalog# 304-1507 KN2738/50 27-802/10 11-134/20 15201/100 KI081/50 11-138S/20 27-734/20 KI079/20 27-784-S/20 TOQ633 KI083K/50 27-774S/20 17125/50 KN1415/10 16-277/20 TOQ630 N0522S/24 TOQ632 15002/100 KI695/20 32-913/20 KI094/50 24-697/20 19-362/20 KI122/20 15302/50 KN2615/10 KN2815/10 KI086S/20 11-177 RED/20 17125/10 KI160/50 17508/24 27-750/20 11-119S/20 KN2805/10 95-551/50 KI074/20 25-711A/20 TD-6008/20 17624/25 KI9390/20 SOAR Portal Tube Catalog# 304-2209 SOAR Portal Tube Catalog# 304-1807 SOAR Beveled Portal Tube Catalog# 306-1806 SOAR Portal Tube Catalog# 304-1203 SOAR Portal Tube Catalog# 304-1209 SOAR Beveled Portal Tube Catalog# 306-2205 SOAR Beveled Portal Tube Catalog# 306-1811 SOAR Portal Tube Catalog# 304-1211 SOAR Portal Tube Catalog# 304-2612 SOAR Beveled Portal Tube Catalog# 306-1510 SOAR Portal Tube Catalog# 304-2208 18345/24 11-185SS/20 312-640/20 HSC001/20 17435/20 KI025/20 17525/25 560-755/01 SOAR Portal Tube Catalog# 304-1512 SOAR Portal Tube Catalog# 304-1812 SOAR Portal Tube Catalog# 304-1804 SOAR Portal Tube Catalog# 304-1511 SOAR Portal Tube Catalog# 304-1508 17408/48 KI118/100 MED27-750/20 17360/25 27-796/20 MAGP01/20 SOAR Portal Tube Catalog# 304-2210 SOAR Portal Tube Catalog# 304-1205 SOAR Portal Tube Catalog# 304-1809 KI069/20 27-790/20 17566/25 25-702/20 GS94-955/01 27-776/20 17130/50 SOAR Portal Tube Catalog# 304-1206 17724/50 KI150/10 KI096S/20 KI0134/20 KIW95/20 24-710/20 17358/25 12-203/20 14901/25 16-296/20 19-360/20 24-689SPC/20 14-256S/20 16-285LR/20 24-663/50 KI051/20 27-763A/20 32-916/20 14-257/20 16-254-LRS/20 Key Surgical® Vascular Loops SOAR Beveled Portal Tube Catalog# 306-1507 SOAR Portal Tube Catalog# 304-1805 SOAR Portal Tube Catalog# 304-2606 KI084/50 25-711/20 25-706/20 19240/25 KI055/20 BHIC01/10 SOAR Portal Tube Catalog# 304-1810 KI084S/20 MED27-734/20 SOAR Portal Tube Catalog# 304-2605 19250/20 15102S/100 KI071/50 15101/100 12-203K/20 KI078/20 KI082/50 17120/50 24-684-A/20 9595/50 28855/20 KI077/20 25-699/50 15202/25 27-736R/60 12-206/20 KI0127/50 MED27-732/20 KN2605/10 25-746/20 KI056/50 17630/20 17713/20 MED25-751/20 SOAR Portal Tube Catalog# 304-1510 18-346/20 SOAR Portal Tube Catalog# 304-1808 11-176 BK/20 27-752/20 TOQ635 17355/50 24-689B/20 15022/50 29-860/20 SOAR Beveled Portal Tube Catalog# 306-2204 SOAR Beveled Portal Tube Catalog# 306-1809 SOAR Portal Tube Catalog# 304-1208 SOAR Portal Tube Catalog# 304-1509 SOAR Beveled Portal Tube Catalog# 306-2208 SOAR Portal Tube Catalog# 304-1806 15232/50 19230/20 KN7516/25 PL-8037/100 KI031/50 24-666/20 19960/10 15301/100 463-004-PK/20 17406/48 KI032/20 19-366/20 KI0154/20 KI076/50 KN2415/10 15000/100 17455/50 13-243/20 14-252/20 KI072/20 KI0104/50 SOAR Portal Tube Catalog# 304-2211 Spineology E Blade Catalog# 315-0014 SOAR Beveled Portal Tube Catalog# 306-1511 SOAR Portal Tube Catalog# 304-2608 SOAR Portal Tube Catalog# 304-2609 KN2515/10 27-732/20 27-732R/60 13-241/20 02-446/20 KI031/20 27-736/20 EWST01/20 14-250/20 403-026-PK/20 27-734R/90 32-915/20 KI095/50 24-712/20 SOAR Portal Tube Catalog# 304-1207 SOAR Beveled Portal Tube Catalog# 306-2210 Spineology Expandable Rake (Non-Toothed) Catalog# 315-0028 SOAR Beveled Portal Tube Catalog# 306-1504 Spineology SIFS Blade Catalog# 330-0012 SOAR Beveled Portal Tube Catalog# 306-1512 SOAR Beveled Portal Tube Catalog# 306-1509 SOAR Portal Tube Catalog# 304-1204 SOAR Portal Tube Catalog# 304-2611 SOAR Beveled Portal Tube Catalog# 306-1810 15221/100 KN2505/10 KI049/20 KI025/10 17050/50 19245/50 25-705/20 KI922/20 19221/20 17618/25 KS355/50 17625/20 02-445/20 KI032/50 27-784/20 MED27-752/20 KI076NT/20 11-159A/20 19227/20 2511/25 15001/100 OEIT01/20 11-139S/20 19902/20 17626/25 11-119C/20 323-01/20 SOAR Beveled Portal Tube Catalog# 306-1808 SOAR Portal Tube Catalog# 304-2206 SOAR Portal Tube Catalog# 304-2212 SOAR Beveled Portal Tube Catalog# 306-1804 SOAR Beveled Portal Tube Catalog# 306-2212 SOAR Beveled Portal Tube Catalog# 306-1506 SOAR Beveled Portal Tube Catalog# 306-2206 MED27-736/20 19-350EFP/50 17432/24 KI130/05 SP55/50 32-911/20 19260/20 KI071/20 25-717/20 15205/100 KI0137/20 KI026/20 KI1107/50 SOAR Beveled Portal Tube Catalog# 306-1812 SOAR Beveled Portal Tube Catalog# 306-2207 SOAR Portal Tube Catalog# 304-2207 SOAR Portal Tube Catalog# 304-1504 17405/10 19-363/50 KI086SS/20 SP62/50 14906/20 16194/25 KIW91/50 SOAR Portal Tube Catalog# 304-1212 SOAR Beveled Portal Tube Catalog# 306-1805 SOAR Portal Tube Catalog# 304-1505 19-349FPS/20 KF305/25 KI086/20 15304/100 NED001/10 25-746S/20 2510/50 SOAR Beveled Portal Tube Catalog# 306-1505 SOAR Portal Tube Catalog# 304-2610 SOAR Portal Tube Catalog# 304-1210 SOAR Portal Tube Catalog# 304-1811 SJM Leaflet Tester Argyle Vascular Tourniquet Kit: 8888585000 SCALPEL, HEMOSTAT, NEEDLE HOLDER, SCISSOR, FORCEP Anspach Bone Collector Y-TEC Peritoneal Dialysis Catheter Implantation Pacs Reprocessed surgical instruments ASPIRATON/ANTICOAGULATION SETS RBC Bag w/ Twist Lock 1000mL HIGHSPEED CELLSAVER5/5+BOWLSET Reservoir Hardhsell, 150U Cell Saver 5/5+ Bowl Kit 225mL Y Connector with Check Valve CELL SAVER, STEP DOWN ADAPTER Y Sets with Extension Line Reservoir Hardshell, 20U Cell Saver 5/5+ BMB Bowl Kit 125mL MCS+ SDP/PLP CON FIL,994CF-CPP DRAINAGE BAG BAG, URINARY DRAIN, VINYL LF ANIT-REFLUX W/FLUTTER VALVE 2000 ML Drain bag holder vinyl Urinary drainage bag 2000cc Urinary drainage bag 2000cc anti reflux chamber Urinary drainage Bag Holder BAG, URINARY DRAIN, VINYL LF ANIT-REFLUX CHAMBER/FLUTTER VALVE 2000 ML Precision: P4A Kengaurd Foley: 3718 MONO-FLO Tray Latex: 6162MF Needleless ULTRAMER Foley: 7016LL CURITY Drain Set: 6261 ULTRAMER Tray with AR Chamber: 894672 Precision: PP16XSD Economy Drainage: 6255 Needleless ULTRAMER Foley: 701672 ULTRAMER Tray with AR Chamber: 8206 Precision: PP14XSD Precision: PP14SD Needleless ULTRAMER Foley: 8948 Needleless PRECISION 400: 7008LL Needleless PRECISION 400: 7008MF Drainge Bag Set: 6300 MONO-FLO Tray Silicone: 6153 MONO-FLO Tray Silicone: 6209 Precision: PA Needleless PRECISION 400: 7012MF Needleless Add-A-Foley: 8256 Needleless ULTRAMER Foley: 701872 MONO-FLO Tray Latex: 6158MF Needleless ULTRAMER Foley: 7018MF Kengaurd Foley: 3502 Needleless ULTRAMER Foley: 8946 Urine Meter Foley: 8324 Drainge Bag Set: 6308LL Needleless ULTRAMER Foley: 7018LL Precision: PP16SD MONO-FLO Tray Latex: 6156MF Precision: PP18CSD Precision: PP16XCSD Needleless PRECISION 400: 7000 Pediatric Drain Bag and meter: 6510 ULTRAMER Tray with AR Chamber: 6948 Urethral Drain Set: 33563 Precision: PP14ULD MONO-FLO Tray Latex: 6156 Urine Meter Foley: 8223 Drainge Bag Set: 6310 Precision: PPAD Precision: PP18XSD Needleless ULTRAMER Foley: 7016MF Drainage Bag B: 6208 Precision: PP18SD Latex Catheter Economy Foley: 6080 MONO-FLO Tray Silicone: 6154 Needleless Add-A-Foley: 7020LL Drainage Bag B: 3057 Needleless ULTRAMER Foley: 8948MF Precision: PP16ULD Pediatric Drain Bag and meter: 6600 Needleless PRECISION 400: 7014MF KENGAURD International Foley: 13720 Needleless PRECISION 400: 7021MF Precision: PP18XCSD Needleless ULTRAMER Foley: 7014LL Precision: P2P Needleless ULTRAMER Foley: 7020MF Needleless PRECISION 400: 7000LL Economy Drainage: 3512 Economy Drainage: 6014 Urethral Drain Set: 6251 Economy Drainage: 3512V KENGAURD International Foley: 13712 CURITY Drain Set: 30510 Pediatric Drain Bag and meter: 145501 ULTRAMER Tray with AR Chamber: 6946 Drainge Bag Set: 6308 MONO-FLO Tray Latex: 6155 MONO-FLO Tray Latex: 6161MF Needleless ULTRAMER Foley: 8946MF Precision: PP18ULD MONO-FLO Tray Latex: 6155MF Kengaurd Foley: 3716 KENGAURD International Foley: 13716 Pediatric Drain Bag and meter: 6770 Precision: PP16CSD Needleless Add-A-Foley: 8256MF KENGAURD International Foley: 13714 KENGAURD International Foley: 13718 Anti-Reflux Bag: 6206 ULTRAMER Tray with AR Chamber: 894872 Kengaurd Foley: 3515

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2013-05-14
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2017-06-20
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-09-20
DQA Oximeter Cardiovascular Class 2 870.2700 2017-07-07
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-05-14
LRS I.V. Start Kit General Hospital Class 2 880.5200 2013-05-14
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-06-27
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2017-07-07
HRX Arthroscope Orthopedic Class 2 888.1100 2019-01-16
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2012-11-30
FDE Laparoscopy Kit Gastroenterology, Urology Class 2 876.1500 2025-06-25
LEC Grinder, Tissue Pathology Class 1 864.3010 2017-07-07
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
FKG Tray, Start/Stop (Including Contents), Dialysis Gastroenterology, Urology Class 1 876.5820 2017-04-26
KNY Accessories, Catheter, G-U Gastroenterology, Urology Class 2 876.5130 2013-05-14
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2017-07-07
OHM Cesarean Section Tray Obstetrics/Gynecology Class 2 884.1720 2017-04-26
SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter Clinical Chemistry Class 2 862.1355 2026-02-03
OVN Suture Kit General, Plastic Surgery Class 2 878.4830 2013-08-23
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2013-05-14
GBS Catheter, Ventricular, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2012-11-01
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2014-03-30
HED Douche Apparatus, Vaginal, Therapeutic Obstetrics/Gynecology Class 1 884.5900 2013-05-14
KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration Gastroenterology, Urology Class 2 876.5980 2017-07-07
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2012-12-04
OHH Breast Pump Kit Obstetrics/Gynecology Class 2 884.5160 2025-08-14
OFF Central Venous Catheter Tray Cardiovascular Class 2 870.1140 2017-04-26
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2017-07-07
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-02-25
OGR Ear, Nose, And Throat Surgical Tray Ear, Nose, Throat Class 1 874.4420 2025-08-14
OFX General Purpose Dental Tray Dental Class 1 872.6640 2017-04-26
PSD Laparoscopic Gastrostomy Kit Gastroenterology, Urology Class 2 876.5980 2025-08-14
FRN Pump, Infusion General Hospital Class 2 880.5725 2023-06-27
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2013-05-14
MLT Pelvic Exam Kit Obstetrics/Gynecology Class 2 884.4530 2017-04-26
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2021-02-09
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-07-11
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2012-11-28
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2013-04-03
OFG Ct Biopsy Tray Cardiovascular Class 2 870.4075 2025-08-14
OIP Radiology-Diagnostic Kit Radiology Class 2 892.1680 2014-02-06
OGJ Nerve Block Tray Anesthesiology Class 2 868.5140 2017-04-26
OFZ Blood Specimen Collection Kit (Excludes Hiv Testing) Anesthesiology Class 1 868.1100 2017-04-26
OJF Hysterectomy Kit Obstetrics/Gynecology Class 2 884.4530 2025-08-14
OES Cardiac Catheterization Kit Cardiovascular Class 2 870.1200 2017-04-26
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2017-07-07
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2017-07-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2026-05-13
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2013-05-14
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-11-01
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2023-06-27
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2017-07-05
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2017-07-05
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2017-07-07
FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation Gastroenterology, Urology Class 2 876.5980 2013-05-14
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2013-05-14
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2013-05-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2013-05-14
FFG Device, Urine Flow Rate Measuring, Non-Electrical, Disposable Gastroenterology, Urology Class 2 876.1800 2013-05-14
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2017-07-05
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-07-05
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2017-07-07
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-02
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2013-05-14
OGE Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2019-07-30
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2013-05-14
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-06-27
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-09
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2013-07-25
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2013-02-04
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2025-07-30
FMJ Manometer, Spinal-Fluid General Hospital Class 2 880.2500 2017-07-07
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2023-03-16
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
OGS Myringotomy Procedure Kit Ear, Nose, Throat Class 2 874.3880 2025-08-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2013-05-14
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-07-07
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-05-14
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2013-05-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-02-09
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-09
OHG Circumcision Tray Obstetrics/Gynecology Class 2 884.4530 2017-04-26
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2013-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2013-05-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2013-05-14
HRX Arthroscope Orthopedic Class 2 888.1100 2013-07-11
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-02-02
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2009-06-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-05-09
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2013-05-14
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-02-25
GAG Stapler, Surgical General Hospital Class 2 878.4740 2025-02-25
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-02-25
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2015-06-30
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2017-05-03
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2017-07-11
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2013-05-14
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2017-07-07
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2016-02-25
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Gastroenterology, Urology Class 2 876.5130 2017-07-07
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2019-01-16
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2013-05-14
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2017-07-07
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2020-12-04
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2020-12-04
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2012-11-30
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2025-08-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-05-10
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2013-05-14
OJK Eye Tray Ophthalmic Class 2 886.4790 2017-04-26
LRS I.V. Start Kit General Hospital Class 2 880.5200 2017-04-26
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2013-05-14
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2013-05-14
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2013-05-14
OJJ Burn Kit Without Drug General, Plastic Surgery Class 1 878.4022 2017-04-26
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2023-06-27
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2026-02-03
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2026-02-03
NWT Endoscopic Cholangiogram Kit Gastroenterology, Urology Class 2 876.1500 2025-08-14
DQA Oximeter Cardiovascular Class 2 870.2700 2017-07-07
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2012-11-01
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2013-04-17
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2012-11-15
OHD Gynecological Laparoscopic Kit Obstetrics/Gynecology Class 2 884.1720 2025-08-14
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2012-12-04
DQA Oximeter Cardiovascular Class 2 870.2700 2013-05-14
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2013-05-14
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-06-27
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2013-05-14
OJG Neurological Tray Neurology Class 1 882.4525 2025-08-14
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2013-05-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
HRX Arthroscope Orthopedic Class 2 888.1100 2013-07-15
OGH Laryngoscope Kit Anesthesiology Class 1 868.5540 2025-08-14
BYZ Trap, Sterile Specimen General Hospital Class 2 880.6740 2016-05-19
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2012-12-04
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2017-07-07
OFO Airway Suction Kit Anesthesiology Class 1 868.6810 2013-08-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-08-16
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2021-02-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-02
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2025-08-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2026-02-03
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2026-02-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-08-16
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2017-07-07
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2012-11-19
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2013-05-14
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-06-27
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2013-05-14
OII Arthrogram Tray Radiology Class 2 892.1650 2025-08-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-11-30
OFQ Anesthesia Kit Anesthesiology Class 2 868.5120 2025-08-14
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2021-02-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-02
OXQ Dressing Change Tray General Hospital Class 1 880.5075 2017-04-26
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2020-11-30
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2012-11-01
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2013-05-14
KSW System, Processing For Frozen Blood Hematology Class 2 864.9145 2023-06-27
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-05-14
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2013-08-23
HGD Applicator, Vaginal Obstetrics/Gynecology Class 1 884.4520 2012-11-30
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2010-06-11
PKF D And C Tray Unknown Class N N/A 2025-08-14
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2013-05-14
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2024-10-22
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2012-11-01
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2023-06-27
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-06-27
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2013-05-14

Official Correspondent

Karen Whaley-Krumins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sotera Health LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005914490 UNIDADE DE ESTERILIZACAO COTIA LTDA. Cotia Sao Paulo, BR
9680579 Sterigenics Radiation Technologies Canada, Inc PORT COQUITLAM British Columbia, CA
3008132411 Sterigenics Shanghai E Beam Ltd. Shanghai, CN
9616517 Sterigenics S. de R.L. de C.V. Tepeji del Rio de Ocampos Hidalgo, MX
3008328679 Sterigenics S. de R.L. de C.V. Cuautitlan Izcalli Mexico, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K233013 Silq Technologies Corporation 2-Way 100% Silicone Cleartract Catheter 2024-01-23
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2029015. Last updated year: 2026. Please use registration number 2029015 when referencing this establishment in official correspondence.
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