Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009888344

FEI Number

3009888344

Entity Name

Isomedix Operations Inc

City/State/Country

El Paso, TX, US

Establishment Address

1441 Don Haskins Dr, El Paso, TX 79936, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 1527821)

Owner / Operator Contact Address

5960 Heisley Rd, --, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Teleflex (EP2) - Midline Catheter Teleflex (EP2) - Arrow Seldinger Arterial Catherization Device Teleflex (EP2) - PICC Avanos2508 (EP1,EP2) - Single Shot Tray Products or Continuous Tray Products Teleflex (EP2) - Large Bore Multi-Lumen CVC Zenflow34605 (TM) - Zenflow Spring Implant Retrieval Device Teleflex (EP2) - Multi-Lumen Acute Hemodialysis Catheter Solventum14471 (SP) - 3M Steri-Drape Teleflex (EP2) - Arrow Epidural Anesthesia Kit Teleflex (EP2) - Flextip Plus Closed Tip Epidural Catheter Teleflex (EP2) - FLEXTIP PLUS CLOSED TIP EPIDUR Teleflex (EP2) - Single Lumen CVC Teleflex (EP2) - Arrow MAC Two-Lumen Central Venous Access Kit Teleflex (EP2) - Arrow Large Bore Dual Lumen Hemodialysis Kit Teleflex (EP2) - Arrow Jugular Puncture Kit Teleflex (EP2) - 19 GA PLASTIC REINFORCED EPIDU Teleflex (EP2) - Pressure Injectable PICC Teleflex (EP2) - Arterial Access Kit Teleflex (EP2) - Arrow Endurance Extended Dwell Peripheral Catheter System Avanos2508 (EP1,EP2) - Kimberly-Clark Teleflex (EP2) - Arrow Pressure Inectable Peripherally Inserted Central Catheter Teleflex (EP2) - Single Lumen CVC Teleflex (EP2) - Arterial Catheter Teleflex (EP2) - Arrow Radial Artery Teleflex (EP2) - StimuCath Contiuous Peripheral Nerve Block Kit Teleflex (EP2) - Arrow Continuous Nerve Block Kit Teleflex (EP2) - Arrow Pressure Injectable Central Venous Catheterization Kit Teleflex (EP2) - Arrow Pressure Injectable Central Venous Catheter Teleflex (EP2) - Arrow Pressure Injectable Midline Catheter Teleflex (EP2) - Introducer Needle Smith&Nephew3754 (NR) - (6) Passing Pins, Drill Tip, 2.7mm x 381mm Smith&Nephew3754 (NR) - 4.5 Incisor S&N3754 (NR) - Drill, 1.6mm and Guide, Dynomite 2 Smith&Nephew3754 (NR) - Drill, 2.6mm and Guide, Raptormite 3 S&N3754 (NR) - Drill, 3.2mm and Guide, Raptormite 3.7 Smith&Nephew3754 (NR) - Drill, 1.8mm and Guide, Spyromite / Minitac2 Wolfmed8101 (MN) - DIAMOND BURR 3MM WL 350MM ROUND Teleflex (EP2) - ATRAUMATIC STANDARD SPROTTE Teleflex (EP2) - Arrow Central Venous Catheterization Kit Ranfac3098 (NR) - ORC-B, ORC-A, LAP-13, ORC-XL11 Ranfac3098 (NR) - Cholangiography Catheter Teleflex (EP2) - Arrow Quickflash Arterial Catheterization Device Avanos2508 (EP1,EP2,NT) - MIC PEG TUBE Avanos2508 (EP1,EP2,NT) - MIC PEG Kit PFMMedical6614 (TM) - 5.5F x 5cm Micro Introducer Kit (Ref M550540) PFMMedical6614 (TM) - 5.5F x 7cm Micro Introducer Kit (Ref M550740) PFMMedical6614 (TM) - 4.5F x 5cm Micro Introducer Kit (Ref M450540) PFMMedical6614 (TM) - 3.5F x 5cm Micro Introducer Kit (Ref M350540) PFMMedical6614 (TM) - 6.5F x 7cm Micro Introducer Kit (Ref M650740) PFMMedical6614 (TM) - 3.5F x 7cm Micro Introducer Kit (Ref M350740) PFMMedical6614 (TM) - 4.5F x 7cm Micro Introducer Kit (Ref M450740) PFMMedical6614 (TM) - 6.5F x 5cm Micro Introducer Kit (Ref M650540) Teleflex (EP2) - Pressure Injectable PICC Teleflex (EP2) - Arrow Pressure Inectable Peripherally Inserted Central Catheter Hollister (SP,LS,LN) - Moderma Flex; New Image; Nova 2; NovaLife 1; NovaLife 1 GX+; NovaLife 2; NovaLife 2 GX+; Pouchkin Hollister (LN, LS) - Ostomy Skin Barriers Hollister (SP,LS,LN) - Premier; Restore; Securi-T USA; Suavita; Tandem; Urostomy Drain Tube Adapter Hollister (LN, LS) - Hollister Hollister (SP,LS,LN) - Adapt; Center Point Lock; Compact; Conform 2; Dansac; Drainable Pouch Clamp; DuoSoft; Fecal Colle Hollister (SP,LS,LN) -First Choice; Holligard; Hollister Solo Stoma Cap; Invent; Karaya 5; Moderma Flex; New Image Teleflex (EP2) - PICC Teleflex (EP2) - ARROW EPIDURAL CATHETERIZATIO Teleflex (EP2) - SPROTTE Teleflex (EP2) - Surgical Drape Teleflex (EP2) - Radial Artery Catheterization Set with Integral Needle Protection Teleflex (EP2) - Arterial Catheter Protech3048 (TM) - Falcon Protech3048 (TM) - Awl Protech3048 (TM) - Lightning Merit1383 (SN) - ShortStop Temporary Sharps Holder Merit1383 (TM) - BackStop Plus Closed Waste Basin Merit1383 (SN) - ShortStop Advantage Temporary Sharps Holder Merit1383 (NT,SN) - ShortStop Advantage Temporary Sharps Holder Ranfac3098 (NR) - SS-1529, Hypodermic Needle, S-115 BVI1689 (CH1,EP1) - Retrobulbar BVI1689 (EP1, CH1) - Peribulbar Clearside6394 (MN,SP) - SCS Microinjector Depuy (NR) - CELLECT BONE MARRO; CONFIDENCE SPINAL CEMENT SYSTEM Ursel11054 (MN) - TRU-CLOSE Suction Drainage System Teleflex (EP2) - Pneumothorax Kit; Pneumothorax kit w/Sutures Teleflex (EP2) - Lake Region Guide Wire TerumoMed3380 (NR) - Mandrel Guidewire Assembly Teleflex (EP2) - Arrow FlexBlock Continous Peripheral Nerve Block Kits Teleflex (EP2) - Arrow Pressure Inectable Peripherally Inserted Central Catheter Avanos2508 (EP1,EP2,NT) - MIC LOW PROFILE GASTROSTOMY TUBE Avanos2508 (EP1,EP2,NT) - CORFLO* PEG Kit Avanos2508 (EP1,EP2) - Gastropexy Kit and Dilator US_Endoscopy4223 (SP) - BioGuard air/water & suction valves-Olympus (3 pc kit) US_Endoscopy4223 (SP) - BioGuard air/water & suction valves-Olympus (4 pc kit) Protech3048 (TM) - Vampiro Avanos2508 (EP1,EP2) - AVANOS* Universal Block Trays Avanos2508 (EP1,EP2) - Prep Trays Avanos2508 (EP1,EP2) - Nerve Block Tray Avanos2508 (EP1,EP2) - Whitacre Needle Avanos2508 (EP1,EP2) - Single Shot Epidural Trays Teleflex (EP2) - Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip Catheter Zimmer (LS) - Creartions SCP Hip Kit Dexcom2055 (EP2) - Dexcom ONE+ Continuous Glucose Monitoring System StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK-SOFT TISSUE FIXATION StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK BONE-TENDON-BONE BVI1689 (EP1) - CustomEyes Zimmer (LN,LS) - Toggleloc Zimmer (LN,LS) - Maxfire Acuderm1463 (WH,LS) -Acu-Punch Kit Teleflex (EP2) - Arrow Pressure Inectable Peripherally Inserted Central Catheter Teleflex (EP2) - Vascular Positioning System (VPS System) Stylet Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC NERVE BLOCK WITH NRFit" CONNECTOR Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Ultrasound Nerve Block Prep Tray Avanos2508 (EP1,EP2) - anesthesia conduction kit - ON-Q* Pain Relief System T-Bloc Continuous Echogenic Nerve Block Tray Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Needle/Catheter Set Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC STIMULATING NERVE BLOCK TRAY WITH NRFit" Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* ECHOGENIC STIMULATING NEEDLE/CATHETER SET WITH NRFit" CONNECTOR Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Continuous Echogenic Stimulating Nerve Block Tray Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* ULTRASOUND NERVE BLOCK PREP TRAY WITH NRFit" CONNECTOR Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Echogenic Needle/Catheter Set Avanos2508 (EP1,EP2) - PERIPHERAL NERVE BLOCK SUPPORT TRAY Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Echogenic Stimulating Needle/Catheter Set Avanos2508 (EP1,EP2) - Endoscopic Accessories Avanos2508 (EP1,EP2) - Cytology Brush Avanos2508 (EP1,EP2) - MIC-KEY and MIC Transgastric Jejunal feeding tubes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PXB	Percutaneous Introducer Kit	General Hospital	Class 2	880.5570	2020-03-20
PAD	Chest Drainage Kit	General Hospital	Class 2	880.6740	2020-03-20
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2012-12-27
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2012-12-27
OFZ	Blood Specimen Collection Kit (Excludes Hiv Testing)	Anesthesiology	Class 1	868.1100	2013-01-28
PYD	Pelviscopy Kit	General, Plastic Surgery	Class 1	878.4800	2020-03-20
PPP	Disposable Joint Aspiration/Injection Kit	General, Plastic Surgery	Class 1	878.4800	2020-03-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-04-22
OFE	Central Venous Blood Pressure Kit	Cardiovascular	Class 2	870.1140	2013-01-28
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-08-27
PXS	Cholecystectomy Kit	General, Plastic Surgery	Class 1	878.4800	2020-03-20
PRV	Gastro-Urology Biopsy Kit	Gastroenterology, Urology	Class 2	876.1075	2019-12-21
PYE	Staple Removal Kit	General, Plastic Surgery	Class 1	878.4760	2020-03-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-08-27
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-08-27
OHZ	Urine Transport Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2013-01-28
OGV	Tracheostomy Cleaning Tray	Anesthesiology	Class 2	868.5800	2013-01-28
OGA	Brachial Plexus Anesthesia Kit	Anesthesiology	Class 2	868.5140	2013-01-28
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-10-31
PZG	Surgical Eye Tray	Ophthalmic	Class 1	886.4350	2020-03-20
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-08-27
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-04-22
OFV	Regional Anesthesia Kit	Anesthesiology	Class 2	868.5120	2013-01-28
OII	Arthrogram Tray	Radiology	Class 2	892.1650	2013-01-28
PYJ	Ulcer Wound Tray	General, Plastic Surgery	Class 1	878.4014	2020-03-20
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2012-12-27
PXZ	Laparascopic Sphincterotomy Kit	General, Plastic Surgery	Class 1	878.4800	2020-03-20
PYC	Paracentesis Tray	General, Plastic Surgery	Class 1	878.4200	2020-03-20
POR	Parenteral Administration Kit	General Hospital	Class 2	880.5440	2020-03-20
OKI	Emergency Response Safety Kit	General, Plastic Surgery	Class 2	878.4040	2013-01-28
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2013-01-28
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2013-01-28
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2013-01-28
MFY	Endothelial Cell Harvesting Kit	Cardiovascular	Class 2	870.4075	2013-01-28
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-01-29
PWO	Blood Administration Kit	General Hospital	Class 2	880.5440	2020-03-20
PYH	Surgical Retractor Kit	General, Plastic Surgery	Class 1	878.4800	2020-03-20
PPR	Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures	Orthopedic	Class 2	888.1100	2020-03-20
OJS	Tourniquet Kit	General, Plastic Surgery	Class 1	878.5900	2013-01-28
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2025-08-27
PRW	Gastrointestinal Tube Kit	Gastroenterology, Urology	Class 2	876.5980	2020-03-20
OGL	Oxygen Administration Kit	Anesthesiology	Class 2	868.5655	2013-01-28
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2013-01-28
MAC	Decontamination Kit	General, Plastic Surgery	Class 1	878.4014	2013-01-28
OFM	Phlebotomy Blood Collection Kit	Cardiovascular	Class 2	870.2750	2013-01-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-11-14
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2018-01-25
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2013-01-28
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2025-08-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-08-27
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2013-01-28
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2012-11-08
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2013-01-28
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-11-14
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2012-10-31
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-08-27
PPQ	Transtibial Anterior Cruciate Ligament Kit	Orthopedic	Class 2	888.3040	2020-03-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-11-15
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2025-08-27
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2012-10-31
OHF	Culdocentesis Kit	Obstetrics/Gynecology	Class 2	884.1640	2013-01-28
OKX	Trocar Kit	Obstetrics/Gynecology	Class 2	884.1720	2013-01-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-08-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-11-15
PQE	Ostomy Care Kit	Gastroenterology, Urology	Class 1	876.5900	2020-03-20
OFT	Spinal Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2013-01-28
PVU	Obstetrical Anesthesia Kit	Obstetrics/Gynecology	Class 2	884.5100	2020-03-20
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2025-08-27
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-08-27
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-08-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-08-27
OIC	Blood Alcohol Kit (Excludes Hiv Testing)	Clinical Toxicology	Class 2	862.3040	2013-01-28
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-08-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-11-14
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-11-14
PWM	Admission Kit (Patient Utensil)	General Hospital	Class 1	880.6730	2020-03-20
PVP	Neurological Test Kit	Neurology	Class 1	882.1750	2020-03-20
OEU	Cardiopulmonary Bypass Catheter Kit	Cardiovascular	Class 2	870.4210	2013-01-28
NYE	Fixture Mount Kit	Dental	Class 1	872.3980	2013-01-28
OIP	Radiology-Diagnostic Kit	Radiology	Class 2	892.1680	2013-01-28
POQ	Blood Transfusion Kit	General Hospital	Class 2	880.5440	2020-03-20
PPC	Male External Catheterization Kit (Excludes Hiv Testing)	Gastroenterology, Urology	Class 2	876.5130	2020-03-20
PVO	Lumbar Drainage Catheter Kit	Neurology	Class 2	882.5550	2020-03-20
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2012-10-31
OJV	Single Use Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2013-01-28
OHE	Forensic Evidence Sexual Assault Kit	Obstetrics/Gynecology	Class 2	884.1630	2013-01-28
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2025-09-17
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2013-01-28
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	Class 2	870.3375	2012-11-14
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-01-29
PPG	Urinary Drainage Collection Kit	Gastroenterology, Urology	Class 2	876.5130	2020-03-20
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2025-08-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-12-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-08-27
OFF	Central Venous Catheter Tray	Cardiovascular	Class 2	870.1140	2013-01-28
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2025-08-27
OKE	Port Introducer Kit	General Hospital	Class 2	880.5965	2013-01-28
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2013-01-28
PYL	Wound Drainage Kit	General, Plastic Surgery	Class 1	878.4014	2020-03-20
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-08-27
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2013-01-28
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2012-12-27
NXA	Tracheotomy Care Kit	Anesthesiology	Class 2	868.5800	2013-01-28
OFK	Percutaneous Atrial Catheter Kit	Cardiovascular	Class 2	870.1250	2013-01-28
PPI	Hemodialysis Tray (Not A Start/Stop Kit)	Gastroenterology, Urology	Class 2	876.5820	2020-03-20
PND	Midline Catheter	General Hospital	Class 2	880.5200	2025-08-27
OIJ	Biopsy Needle Guide Kit	Radiology	Class 2	892.1560	2013-01-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-08-27
OGP	Cricothyrotomy Kit	Anesthesiology	Class 2	868.5800	2013-01-28
PXV	General Purpose Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2020-03-20
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-12-27
OKU	Emergency Obstetrical Kit	Obstetrics/Gynecology	Class 1	884.4520	2013-01-28
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2025-08-27
OGJ	Nerve Block Tray	Anesthesiology	Class 2	868.5140	2013-01-28
OFO	Airway Suction Kit	Anesthesiology	Class 1	868.6810	2013-01-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-11-14
OHH	Breast Pump Kit	Obstetrics/Gynecology	Class 2	884.5160	2013-01-28
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	Class 2	870.3375	2014-11-07
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-04-23
PKF	D And C Tray	Unknown	Class N	N/A	2020-03-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-08-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-11-13
PXX	Incision Tray	General, Plastic Surgery	Class 1	878.4800	2020-03-20
KYP	Snake Bite Suction Kit	General Hospital	Class 1	880.5740	2012-12-27
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2012-12-27
OGR	Ear, Nose, And Throat Surgical Tray	Ear, Nose, Throat	Class 1	874.4420	2013-01-28
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2013-01-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-04-02
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2021-08-13
NLG	Catheter, Intracardiac Mapping, High-Density, Reprocessed	Cardiovascular	Class 2	870.1220	2021-08-13
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2012-12-27
PVW	Pudendal Anesthesia Kit	Obstetrics/Gynecology	Class 2	884.5100	2020-03-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-08-27
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-10-31
OGD	Custom Anesthesia Tray	Anesthesiology	Class 2	868.5120	2013-01-28
PSK	Replacement Gastrostomy Feeding Catheter Tray	Gastroenterology, Urology	Class 2	876.5980	2020-03-20
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2013-01-28
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2019-10-17
PXQ	Burn Dressing Tray	General, Plastic Surgery	Class 1	878.4022	2020-03-20
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2003-05-01
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-11-14
PXW	Herniorraphy Kit	General, Plastic Surgery	Class 1	878.4800	2020-03-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-03-12
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-08-27
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2013-01-28
OFG	Ct Biopsy Tray	Cardiovascular	Class 2	870.4075	2013-01-28
OFW	Restorative Instrument And Component Tray	Dental	Class 2	872.3690	2013-01-28
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2012-10-26
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-08-27
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2012-11-08
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2025-08-27
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2018-11-15
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-08-27
PYF	Sterile Puncture Tray	General, Plastic Surgery	Class 1	878.4800	2020-03-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-08-27
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-04-22
OHL	Pap Smear Kit	Obstetrics/Gynecology	Class 2	884.4530	2013-01-28
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2019-12-19
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2022-04-22
OGS	Myringotomy Procedure Kit	Ear, Nose, Throat	Class 2	874.3880	2013-01-28
PXY	Irrigation Kit (Wounds)	General, Plastic Surgery	Class 1	878.4014	2020-03-20
PVM	Endoscopic Ventricular Catheter Placement Kit	Neurology	Class 2	882.4100	2020-03-20
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2013-01-28
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2013-01-28
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-04-20
MLT	Pelvic Exam Kit	Obstetrics/Gynecology	Class 2	884.4530	2013-01-28
PEV	Dialysis Administration Kit	Gastroenterology, Urology	Class 2	876.5820	2018-09-24
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-11-13
OFB	Catheter Guide Wire Kit	Cardiovascular	Class 2	870.1330	2013-01-28
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-11-07
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-11-14
PYG	Suction Catheter Kit	General, Plastic Surgery	Class 1	878.4200	2020-03-20
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2013-01-28
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-04-02
OKY	Cytology Kit	Obstetrics/Gynecology	Class 2	884.4530	2013-01-28
OGC	Continuous Brachial Plexus Block Tray	Anesthesiology	Class 2	868.5150	2013-01-28
PSG	Percutaneous Endoscopic Gastrostomy Kit	Gastroenterology, Urology	Class 2	876.5980	2020-03-20
OFI	Laser Blood Flow Kit	Cardiovascular	Class 2	870.2120	2013-01-28
PRR	Feeding Tube Kit	Gastroenterology, Urology	Class 2	876.5980	2020-03-20
OKH	Body Fluids Barrier Kit	General, Plastic Surgery	Class 2	878.4040	2013-01-28
DWZ	Device, Biopsy, Endomyocardial	Cardiovascular	Class 2	870.4075	2017-11-13
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2024-03-14
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2012-12-27
OGU	Pierced Ear/Entry Cleaning Tray	Ear, Nose, Throat	Class 1	874.4420	2013-01-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-01-07
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2022-04-23
PYK	Venous Ulcer Kit	General, Plastic Surgery	Class 1	878.4014	2020-03-20
PRY	Gastrostomy Jejunostomy Feeding Tube Kit	Gastroenterology, Urology	Class 2	876.5980	2020-03-20
PWZ	Mid-Stream Collection Kit	General Hospital	Class 1	880.6730	2020-03-20
PVS	Fetal Blood Sampling Kit (Excludes Hiv Testing)	Obstetrics/Gynecology	Class 2	884.1560	2020-03-20
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2013-01-28
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2025-08-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-01-29
PPB	Foley Catheter Kit (Excludes Hiv Testing)	Gastroenterology, Urology	Class 2	876.5130	2020-03-20
PKE	Laparoscopic Cholecystectomy Kit	General, Plastic Surgery	Class 1	878.4800	2020-03-20
PWU	Clean-Up Kit	General Hospital	Class 1	880.6890	2020-03-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-11-14
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2013-01-28
OKW	Seminal Fluid Collection Kit	Obstetrics/Gynecology	Class 2	884.5300	2013-01-28
PWL	Oral Surgery Tray	Dental	Class 1	872.4565	2020-03-20
NYF	Gingival Retraction Kit	Dental	Class 1	872.4565	2013-01-28
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2020-03-20
OKZ	Endometrial Sampling Kit	Obstetrics/Gynecology	Class 2	884.1175	2013-01-28
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2025-08-27
OHD	Gynecological Laparoscopic Kit	Obstetrics/Gynecology	Class 2	884.1720	2013-01-28
PXP	Breast Biopsy / Localization Tray	General, Plastic Surgery	Class 1	878.4800	2020-03-20
PXN	Basic Set-Up Tray	General, Plastic Surgery	Class 1	878.4800	2020-03-20
PSB	Nasogastric Feed Tube Kit	Gastroenterology, Urology	Class 2	876.5980	2020-03-20
NYH	Plaque Disclosing Kit	Dental	Class 2	872.1740	2013-01-28
PFU	Tissue Processing Kit	Unknown	Class N	N/A	2020-03-20
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2012-10-31
PPO	Multi-Lumen Hemodialysis Catheterization Kit	Gastroenterology, Urology	Class 2	876.5540	2020-03-20
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2012-12-27
OKG	Body Fluid Clean Up Kit	General, Plastic Surgery	Class 2	878.4040	2013-01-28
PXO	Bone Marrow Biopsy Tray	General, Plastic Surgery	Class 1	878.4800	2020-03-20
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-01-29
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-08-27
NYC	Dental Prophylaxis Kit	Dental	Class 1	872.4565	2013-01-28
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2013-01-28
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2013-01-28
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-04-23
PPH	Single Needle With Uni-Directional Pump Kit	Gastroenterology, Urology	Class 2	876.5820	2020-03-20
PSI	Perineal Irrigation Kit	Gastroenterology, Urology	Class 2	876.5980	2020-03-20
PPF	Urinary Irrigation Kit	Gastroenterology, Urology	Class 2	876.5130	2020-03-20
OGF	Glossopharyngeal Anesthesia Kit	Anesthesiology	Class 2	868.5120	2013-01-28
KGC	Tube, Gastro-Enterostomy	Gastroenterology, Urology	Class 2	876.5980	2012-10-31
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2017-11-13
PXC	Personal Protection Kit	General Hospital	Class 1	880.6250	2020-03-20
PRT	Gastric Irrigation And Aspiration Kit	Gastroenterology, Urology	Class 2	876.5980	2019-12-28
PPD	Universal Drainage Tray	Gastroenterology, Urology	Class 2	876.5130	2020-03-20
NYD	Endodontic Kit	Dental	Class 2	872.3820	2013-01-28
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2012-12-27
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-01-29
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2012-10-31
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2001-08-06
OFL	Percutaneous Sheath Introducer Kit	Cardiovascular	Class 2	870.1340	2013-01-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-04-12
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2013-01-28
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-10-24
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2013-01-29
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2013-01-29
OFR	Tracheobronchial Suction Catheter Kit	Anesthesiology	Class 1	868.6810	2018-09-24
OFH	Digital Angiography Tray	Cardiovascular	Class 2	870.1650	2013-01-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-08-27
PKD	Laceration Tray	General, Plastic Surgery	Class 1	878.4014	2020-03-20
OER	Angioscopic Valvulotome Kit	Cardiovascular	Class 2	870.1650	2013-01-28
PPK	Peritoneal Dialysis Tubing Kit	Gastroenterology, Urology	Class 2	876.5630	2020-03-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-11-14
NWI	Electrosurgical Electrode Kit	Gastroenterology, Urology	Class 2	876.4300	2013-01-28
OET	Cardioplegia Solution Administration Kit	Cardiovascular	Class 2	870.4240	2013-01-28
SAF	Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter	Clinical Chemistry	Class 2	862.1355	2025-12-15
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2013-01-28
OFQ	Anesthesia Kit	Anesthesiology	Class 2	868.5120	2013-01-28
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-12-27
OGW	Tracheostomy Kit	Anesthesiology	Class 2	868.5800	2013-01-28
OHC	Obstetrical Vacuum Delivery Kit	Obstetrics/Gynecology	Class 2	884.4340	2013-01-28
PVX	Vaginal Examination Tray	Obstetrics/Gynecology	Class 2	884.4530	2020-03-20
PXM	Vomitus Clean-Up Kit	General Hospital	Class 1	880.6890	2020-03-20
PXU	Fluid Drainage Tray	General, Plastic Surgery	Class 1	878.4200	2020-03-20
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2026-02-13
OFY	Dental Implant Surgical Tray	Dental	Class 1	872.3980	2013-01-28
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-11-14
OGI	Nasal Endotracheal Tube Holder Kit	Anesthesiology	Class 1	868.5770	2013-01-28
NYG	Lapping Tool Kit	Dental	Class 1	872.4565	2013-01-28
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2012-10-31
EBO	Denture Repair Kit	Dental	Class 2	872.3570	2013-01-28
OKF	Body Fluid Disposal Kit	General, Plastic Surgery	Class 2	878.4040	2013-01-28
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2022-04-22
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-12-28
PVL	Endoscopic Shunt Placement Kit	Neurology	Class 2	882.5550	2020-03-20
PXI	Thoracentesis Tray	General Hospital	Class 2	880.5570	2020-03-20
OHM	Cesarean Section Tray	Obstetrics/Gynecology	Class 2	884.1720	2013-01-28
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2013-01-28
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-08-27
PVY	Vasovasostomy Set	Gastroenterology, Urology	Class 1	876.4730	2020-03-20
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-01-29
LRQ	Tracheostomy And Nasal Suctioning Kit	Unknown	Class 1	N/A	2013-01-28
OEX	Cardiovascular Catheter Sheath Introducer Kit	Cardiovascular	Class 2	870.1340	2013-01-28
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-08-27
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2022-04-25
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2012-10-31
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2012-10-31
PSC	Nasogastric-Gastrojejunal Kit	Gastroenterology, Urology	Class 2	876.5980	2020-03-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-10-31
OFN	Winged Intravenous Catheterization Kit	Cardiovascular	Class 2	870.1200	2013-01-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

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3018811167	MEDIVATORS INC	Rogers, MN, US
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3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Z-0004-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0025-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Z-0026-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Z-0027-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009888344. Last updated year: 2026. Please use registration number 3009888344 when referencing this establishment in official correspondence.