Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1422634

FEI Number

1000514656

Entity Name

MEDLINE INDUSTRIES, LP (Northpoint Services)

City/State/Country

Waukegan, IL, US

Establishment Address

1160 S. Northpoint Blvd., Waukegan, IL 60085, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Medline Industries, LP (Owner Number: 1417592)

Owner / Operator Contact Address

Three Lakes Drive, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medline / CDS catheter introducer kit DYNACOR CONTAINERS Medline/Centurion Sterile Bowl, Sterile Pitcher Medline Pathology Container Centurion Pathology Container Medline Midstream Collection Kit Medline Specimen Container NAMIC Perceptor DT Monitoring Kit NAMIC Perceptor DT Standard Pole Mount Kit NAMIC Perceptor DT Pressuring Monitoring Kit NAMIC Perceptor DT Disposable Transducer Medline Access Care Kit Medline Dialysis Tray Centurion Dialysis Tray Medline Eye Pad Medline/Konig Uterine Sound Medline / CDS cardiac catheterization kit Medline rectal tube MEDLINE Applicator for rectal suppository - OOW AVENUE Insertion Tool Feeding Tube PVC ENFit FdTube Medline surgical kits/trays and CDS modules MEDLINE General surgery tray (kit) Medline / Eclipse / Aurora / Sirus surgical packs Convenience Trays & Kits CSTM Medline Proxima ENFit Protection Plus Disposable Underpads Medline Disposable Underpads FitRight Ultrasorb, Extrasorb, Therasorb, Drypad, Underpads OREX MEDICAL BEDDING DISPOSABLE BEDDING CleanOp: bedding and cleaning supplies Microtek Disposable Baby Blanket Extrasorb MICROTEK DISPOSABLE BEDDING FitRight Extended Use Underpad BEDDING Ultrasorb MEDICAL GENERAL HOSPITAL ComfortGlide Drypad MIRROR, ENT DuoCare Pint-Sized Medline Medline/Konig Cardiovascular Surgical Instruments NAMIC Bottle/SOSA Spike Clip Medline arterial needle Medline Skin Marker NAMIC Contrast Management System NAMIC Contrast Controller NAMIC Squeeze Contrast Controller Medline Vessel Cannula MEDLINE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS - DWF Eclipse Surgical Drape Medline Surgical Drape Medline Keyboard Cover Medline Band Bag Medline Set Up Cover Vari-Lens Lingeman Procept AKTORmed Microtek Patient Drapes Medline Dome Bag Convertors Vital Care Perfect Pouch OnLume Medline Poly-lined Drape Medline Poly-lined Fenestrated Drape Medline Equipment Cover Microtek Probe Cover Microtek Equipment Drapes HANDLE, SCALPEL Tubing, fluid delivery Caring+ Optifoam Gentle Surgical Max Optifoam Gentle SA Optifoam Gentle Liquitrap (LQ) Optifoam Gentle Heel Optifoam Gentle Lite Medline Wound Dressing Optifoam SureSite Optifoam Gentle Stratasorb Opticell Gelling Fiber Wound Dressing Medline Bordered Gauze Adhesive Island Versatel Optiview Optifoam Basic Optifoam Heel Exuderm Low Profile (LP) CURAD Exuderm Satin Optifoam Gentle EX Essentials Optifoam Site Equos CURAD Naturals Medline Optifoam Gentle Post-Op The Grip Torque Device Medline / CDS maternity kit MEDLINE Labor and Delivery Kit - MLS angioOCCLUDE Manifold, Stopcock, and Adapter MEDLINE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS Medline M/M Adapter NAMIC 3-Way Stopcock NAMIC Adaptors/Connectors Push Style Y-Adapter INSTRUMENT, MANUAL, GENERAL OBSTETRIC-GYNECOLOGIC Medline / CDS skin prep tray (kit) 946240-Skin Prep CSTM Symphony Accessory Pack Wet Skin Prep Tray with Povidone Iodine Scrub and Paint Solution Dry Skin Surgical Scrub Tray with Gauze, Premium Dry Surgical Scrub Tray Medline/Konig Hook, Surgical, General & Plastic Surgery Medline / Konig Speculum, Vaginal, Metal ST.PEDERSON VAGINAL SPECULUM MEDLINE / CENTURION STERILE GRAVES VAGINAL SPECULUM MEDLINE / CENTURION STERILE VAGINAL SPECULUM CLAMP, CIRCUMCISION 170019-Convenience Trays & Kits CSTM Medline General Surgery Tray Medline Basin Tray Eclipse Surgical Pack Medline surgical kits/trays and CDS modules Aurora Surgical Pack Sirus Surgical Pack Wire, guide, catheter Medline / Konig Tray, Surgical, Instrument Medline Mayo Stand Medline Magnetic Instrument Mat Medline / CDS surgical instrument tray Medline Suture Boot Medline / CDS circumcision tray (kit) 147572-Sterile Circumcision Tray CSTM Medline / CDS cardiac catheterization kit NAMIC Fluid Delivery Set NAMIC Protection Station NAMIC Sosa Spike NAMIC Fluid Administration Set NAMIC Closed Fluid Systems NAMIC Filling Station NAMIC Filling Station Plus NAMIC Contrast Removal Valve NAMIC Protection Station Plus NAMIC Tri-Adaptor NAMIC Y-Adaptor NAMIC Tri-Adaptor Kit NAMIC Y-Adaptor Kit NAMIC Perceptor Manifold NAMIC Standard Angiographic Kit Medline Gastric Sump Tube BULKEE II CURAD BULKEE LITE Caring abdominal pads CURAD Naturals Medline Abdominal Pad Medline ACCU-SORB Navilyst Medical Convenience Kit Medline Angiography/Angioplasty Kit Essentials Kit Medline/Konig Curette Medline Scoop Curette Medline Catheter Leg Strap Medline Urethral Catheter Holder Medline Foley Catheter Securement Device Medline Epidural / Spinal Needles MEDLINE NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) - BSP Medline ORLocate Sponge MedFix ACCU-SORB NE1 Wound Assessment Tool Medline/Konig Medline Tape Measure ViperTrack Medline/Konig Electrosurgical, Cutting & Coagulation & Accessories Medline Electrosurgical Pencil / Pad / Accessory MEDLINE CATHETER, INTRAVASCULAR, DIAGNOSTIC - DQO Medline High Pressure Tubing Medline ADAPTOR, DRESSING NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) Medline Wound Dressing Kit Medline Clearpro Closed Suction Catheter Medline Tracheobronchial Suction Catheter Medline Open Suction Catheter Centurion Forceps Medline / Konig Forceps, General & Plastic Surgery ELECTROSURGICAL PENCIL WITH ELECTRODE Intopo TL Non-vented Cap Gravifeed TL ENFit Tubing Introducer Cannula Electrode Medline General Purpose Dental Tray Restraint, protective FORCEPS, TUBE INTRODUCTION Medline Laceration Tray Medline Surgical Shave Prep Tray Medline Convenience Trays & Kits CSTM Medline Double / Single Basin Trays Medline surgical kits/trays and CDS modules Medline UNITE Joint Prep Kit Medline Needle Counter SURGICAL LEGGINGS Medline Coveralls AngelStat Medline Medline / Konig Scissors, Orthopedic, Surgical Medline Catheter Plug and Drain Tube Protector Centurion Catheterization Kit Medline Catheterization Kit Secureview SorbaView 2000 Medline SeeIV SorbaView SorbaView SHIELD HubGuard NAMIC Contrast Injection Line Medline Medline Basin Kit Centurion Basin Kit APOLLO REVISE System APOLLO REVISE SX System APOLLO ESG SX System APOLLO ESG System NAMIC Saver-7; Angiographic Control Syringe NAMIC Acceler-8; Angiographic Control Syringe NAMIC Mounting Bracket/Plate NAMIC DT Clamp Angio-SAC Collection System NAMIC Angiographic Bags Medline Decontamination Kit Medline M/M Adapter MEDLINE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS - DTL Medline stopcock / manifold Medline/Konig Speculum, ENT Medline Nasal Speculum Medline Suture Boot Medline Double Mesh Strainer Medline Towel Clamps/Sponge Forceps Medline Surgical Instrument Centurion Cuticle and Tissue Nippers NAMIC Pediatric Pressure Monitoring Lines NAMIC Adaptor NAMIC Pressure Monitoring Lines Medline Breast Pump Kit Colostrum Collect Store Medline Cardiovascular Procedure Kit Medline CURAD Meijer System, irrigation, urological EnFit Straw TL GTube Enteral Straw ENFit ExSet TL ExSet MEDLINE LABEL OR TAG, STERILE Medline Pelvic Exam Kit Medline UNITE Komet Rasps Medline/Konig Surgical Saw Blade ExpressAire Tourniquet Cuff Color Cuff Disposable Tourniquet Color Cuff Cylindrical Tourniquet Tourniquet Cuff STIC Intra-Compartmental Pressure Monitor System Medline Cotton-Tipped Applicators Scraper, Vaginal/Cervical Applicator, Vaginal/Cervical MEDLINE APPLICATOR, VAGINAL - HGD Medline / Konig Speculum, Rectal NAMIC Control Syringes angioLOCK Clip, vascular / clip, implantable Pad, alcohol, device disinfectant Summit / Infinity OR towels Medline OR Towels Ultrasorbs Dry Sheets ORLocate Towels Medline Cotton Balls Catheter, intravascular, therapeutic, short-term less than 30 days Set, administration, intravascular Medline NAMIC Stopcock NAMIC Port Protector Medline/Konig Clamp PerClot Medline Suture Removal Tray 140928-Suture Removal Kit CSTM Medline suction coagulator Medline / CDS central venous catheter tray (kit) SYSTEM, URINE DRAINAGE, CLOSED, FOR NON-INDWELLING CATHETER, NON-STERILE Medline / Konig Razor, Surgical Carefusion Clipper Blade Medline Clipper Blade Medline Surgical Clipper Medline Razor MEDLINE TRAY, SURGICAL - LRP Medline/Konig Surgical Tray 137075-Surgical SetUp CSTM Medline Count Sheet Holder Introducer, catheter Medline Surgical Stapler NAMIC Torque Device NAMIC Guidewire Introducer MedFix EZ Sorbaview Polar Dressing CURAD SureSite Roll Medline Bordered Gauze Gentac EZ MedFix StickRight CURAD Naturals Stickright Pinc Medline Tracheostomy And Nasal Suctioning Kit Centurion Tracheostomy And Nasal Suctioning Kit MEDLINE / CDS PLASTIC SURGERY KIT AND ACCESSORIES Medline Biohazard Specimen Bag Medline Pathology Container Medline Specimen Container NAMIC Perceptor Compensator Manifold Medline Critical Response Remote Control Drape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OFD	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2008-07-15
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	1992-01-09
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2019-11-04
FKG	Tray, Start/Stop (Including Contents), Dialysis	Gastroenterology, Urology	Class 1	876.5820	2015-01-19
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2017-11-14
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2015-04-27
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2015-12-15
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2008-07-09
OOW	Applicator For Rectal Suppository	Gastroenterology, Urology	Class 1	876.4730	2012-08-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-11-04
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2026-06-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-01-13
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2016-01-13
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2016-01-13
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2019-02-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-01-13
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-06-04
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2014-10-20
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2023-08-01
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2018-02-16
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-02-14
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-05-17
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-05-17
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2005-02-01
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2014-03-17
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-01-13
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2019-11-04
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2015-04-08
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2011-07-25
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-25
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2015-03-31
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2023-03-30
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-04-04
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2019-11-04
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2008-07-09
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-06-04
DSS	Clip, Vascular	Cardiovascular	Class 2	870.3250	2026-06-04
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-02-27
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2022-11-10
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2010-08-09
LKK	Pump, Infusion, Implanted, Programmable	Unknown	Class 3	N/A	2016-07-14
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-04-08
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2015-03-31
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2023-06-22
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2016-05-17
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2015-12-15
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2016-08-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-01-13
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2006-08-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-03-26
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-01-13
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2016-08-22
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1995-06-05
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2011-09-07
OHG	Circumcision Tray	Obstetrics/Gynecology	Class 2	884.4530	2010-08-09
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2008-07-09
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2013-09-09
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2013-09-09
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4420	2016-01-13
DTY	Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4410	2016-01-13
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2015-12-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-11-04
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-11-12
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2019-11-04
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-02-11
HFE	Brush, Endometrial	Obstetrics/Gynecology	Class 2	884.1100	2016-01-13
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2002-12-13
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2008-07-09
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2019-11-04
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2015-04-08
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	1991-12-30
HHI	System, Abortion, Vacuum	Obstetrics/Gynecology	Class 2	884.5070	2016-08-22
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-07-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-01-13
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2011-07-25
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-05-17
LHG	Electrode, Spinal Epidural	Neurology	Class 2	882.5880	2015-12-15
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2015-12-15
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	1992-06-15
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2015-02-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-05-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-05-16
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-08-20
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2016-01-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-01-13
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2025-03-24
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2009-01-16
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2008-07-10
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2005-02-01
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-03-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-07-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-06-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-04-24
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-09-09
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2016-04-15
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2025-03-26
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2023-03-30
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	1979-05-15
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-08-19
HGF	Source, Abortion Unit, Vacuum	Obstetrics/Gynecology	Class 2	884.5070	2016-08-22
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2016-01-13
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	1992-01-10
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2015-03-31
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-01-13
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-01-30
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2018-04-06
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-01-13
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-10-24
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	1991-12-30
QTD	Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss	Gastroenterology, Urology	Class 2	876.5983	2023-07-17
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2019-11-12
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2019-10-24
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-10-22
MAC	Decontamination Kit	General, Plastic Surgery	Class 1	878.4014	2015-12-09
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2012-04-09
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2015-04-08
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	1987-01-05
DRI	Monitor, Line Isolation	Cardiovascular	Class 1	870.2620	2019-11-12
OFS	Tracheal Suction Set	Anesthesiology	Class 1	868.6810	2016-05-17
OHH	Breast Pump Kit	Obstetrics/Gynecology	Class 2	884.5160	2016-05-17
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2008-07-15
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2009-11-19
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-03-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-06-04
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-11-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-01-13
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2011-09-03
MLT	Pelvic Exam Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-05-13
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2015-04-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-01-13
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2026-06-04
LXC	Monitor, Pressure, Intracompartmental	Unknown	Class U	N/A	2026-06-04
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2016-02-16
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2016-05-17
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2011-09-23
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-01-13
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2015-03-31
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2019-10-24
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-05-05
DSS	Clip, Vascular	Cardiovascular	Class 2	870.3250	2026-05-05
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2016-01-13
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2025-03-26
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	1996-09-24
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2023-03-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-03-30
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	1982-09-17
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-01-13
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-10-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-01-13
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2015-04-27
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	General, Plastic Surgery	Class 3	878.4490	2025-03-25
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2015-12-09
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2016-05-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-12-02
FNN	Nipple, Lambs Feeding	General Hospital	Class 1	880.5640	2016-05-17
OFF	Central Venous Catheter Tray	Cardiovascular	Class 2	870.1140	2008-07-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-01-13
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-03-24
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-11-18
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	1991-12-30
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2016-01-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-01-13
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2015-12-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-03-30
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2011-09-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2019-11-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2000-02-07
LRQ	Tracheostomy And Nasal Suctioning Kit	Unknown	Class 1	N/A	2021-03-08
HDY	Dilator, Cervical, Hygroscopic-Laminaria	Obstetrics/Gynecology	Class 2	884.4260	2016-08-22
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2011-09-15
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2009-06-19
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2019-11-04
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2020-07-28
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2016-01-13

Official Correspondent

Stephanie Augsburg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medline Industries, LP

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190960	Boston Scientific Neuromodulation	Nalu Lead Blank (50cm)	2019-07-11
K150517	Stimwave Technologies Incorporated	Freedom Spinal Cord Stimulator System	2015-06-05
K945103	Medtronic Vascular	TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)	1995-01-11
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2012	Deroyal Industries, Inc. Lafollette	2	DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
Z-0027-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND

Similar Registrations

Registration Number	Establishment Name	Location
3005012805	MIDWEST STERILIZATION CORP.	LAREDO, TX, US
1030451	MEDICAL ACTION INDUSTRIES, INC. 306	ARDEN, NC, US
3009746061	Integra Biotechnical, SA de CV	Tijuana Baja California, MX
3035642068	Honduras Kitting, S.A.	Villanueva Cortes, HN
1526863	ICU Medical, Inc.	DUBLIN, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1422634. Last updated year: 2026. Please use registration number 1422634 when referencing this establishment in official correspondence.