Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1423395

FEI Number

3000717925

Entity Name

MEDLINE INDUSTRIES, LP - SPT

City/State/Country

Waukegan, IL, US

Establishment Address

1170 S Northpoint Blvd, Waukegan, IL 60085, US

Establishment Type(s)

Repack or Relabel Medical Device

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

K120069

PMA Number

N/A

All Registered Proprietary Names

Medline Blood Pressure Transducer Electrosurgical, cutting & coagulation & accessories Medline Electrocautery Pencil MedFix EZ Sorbaview Polar Dressing CURAD SureSite Roll Medline Bordered Gauze Gentac EZ MedFix StickRight CURAD Naturals Stickright Pinc Medline / CDS cardiac catheterization kit Medline Breathing Circuit Medline Adult Expandable Anesthesia Circuit MEDLINE BIPOLAR FORCEPS 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 Medline Electrosurgical Tip IV Kit Medline / CDS laparoscopy kit Medline Laceration Tray Medline Tracheobronchial Suction Catheter Kit Medline D407 Series Sleeved Suction Catheter Kit Medline Suction Catheter Mini Tray Medline D409 Series Suction Catheter Kit Medline Suction Catheter Kit Cautery Pencil Electrosurgical, cutting & coagulation & accessories Medline Suture Boot Medline Double Mesh Strainer Medline Towel Clamps/Sponge Forceps Medline Surgical Instrument Centurion Cuticle and Tissue Nippers Medline Central Venous Catheter Dressing Change Kit Medline Feather Blades 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 / CDS biopsy tray or kit Medline Lumbar Puncture Tray 321236-Sterile Biospy CSTM Medline / CDS arthrogram tray Medline Cautery Electrode (PTFE) Medline Stainless Steel Electrodes 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 Medline / CDS circumcision tray (kit) 147572-Sterile Circumcision Tray CSTM Medline surgical kits/trays and CDS modules MEDLINE General surgery tray (kit) Medline / Eclipse / Aurora / Sirus surgical packs Convenience Trays & Kits CSTM Medline Proxima Medline Trach Kit Medline Tracheotomy Care Tray Blue Silk PTFE-coated Electrodes Medline General Purpose Dental Tray Surgical Instrument Kit Medline Nylex Covered Foam Medline / CDS obstetrical kit Medline Pelvic Exam Kit Manifold Medline Medline Basin Kit Centurion Basin Kit Medline BULKEE II CURAD BULKEE LITE Caring abdominal pads CURAD Naturals Medline Abdominal Pad Medline ACCU-SORB Cautery Tip Medline Smoke Evacuation Pencil High Pressure Tubing with Rotator Medline ORLocate Sponge MedFix ACCU-SORB Navilyst Medical Convenience Kit Medline Angiography/Angioplasty Kit Medline Dialysis Tray Medline Access Care Kit CURAD Naturals Medline Medline / CDS nuerological tray (kit) Orthopedic Kits General and Plastic Surgery Kits Foley Catheter Insertion Tray Cardiovascular Kits Clinical Chemistry and Clinical Toxicology Kits Anesthesiology Kits Obstetrical and Gynecological Kits General Hospital and Personal Use Kits Dental Kits Medline General Surgery Tray Ear, Nose, and Throat Kits Physical Medicine Kits Gastroenterology-Urology Kits Radiology Kits Ophthalmic Kits Neurological Kits Medline patient personal hygiene kit MEDLINE / CDS PLASTIC SURGERY KIT AND ACCESSORIES Medline / CDS maternity kit MEDLINE Labor and Delivery Kit - MLS MEDLINE LABEL OR TAG, STERILE Medline Body Fluid Disposal Kit Medline Blood And Urine Collection Kit (Excludes Hiv Testing) Medline Endo Kit Medline Endoscope Introducer Kit Medline / CDS hysterectomy kit (tray) 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 M/M Adapter MEDLINE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS - DTL Medline stopcock / manifold

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2013-06-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-06-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-05-09
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2000-02-07
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2008-07-09
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2006-04-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-11-04
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-02-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-04-21
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2008-07-09
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2010-08-09
PKD	Laceration Tray	General, Plastic Surgery	Class 1	878.4014	2015-12-09
OFR	Tracheobronchial Suction Catheter Kit	Anesthesiology	Class 1	868.6810	2008-07-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-06-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-06-05
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	1987-01-05
PEZ	Central Venous Catheter Dressing Change Kit	General Hospital	Class 2	880.5200	2015-12-16
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1992-01-09
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2010-08-09
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	1997-06-13
OII	Arthrogram Tray	Radiology	Class 2	892.1650	2010-08-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-04-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-03-24
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-25
OHG	Circumcision Tray	Obstetrics/Gynecology	Class 2	884.4530	2010-08-09
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2019-02-28
NXA	Tracheotomy Care Kit	Anesthesiology	Class 2	868.5800	2008-07-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-03-24
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2016-04-15
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2026-06-05
OKV	Obstetrical Kit	Obstetrics/Gynecology	Class 2	884.4520	2011-09-15
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-03-24
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	1991-12-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-11-20
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2002-12-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-11-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-11-19
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-03-24
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	1992-06-15
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2008-07-09
PEV	Dialysis Administration Kit	Gastroenterology, Urology	Class 2	876.5820	2015-01-20
OJJ	Burn Kit Without Drug	General, Plastic Surgery	Class 1	878.4022	2011-09-15
OJG	Neurological Tray	Neurology	Class 1	882.4525	2010-08-09
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2023-10-24
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2006-02-01
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-07-21
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2011-09-15
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2008-07-09
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2011-09-03
OKF	Body Fluid Disposal Kit	General, Plastic Surgery	Class 2	878.4040	2015-12-24
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2015-12-09
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2015-12-16
OJF	Hysterectomy Kit	Obstetrics/Gynecology	Class 2	884.4530	2011-09-15
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	1979-05-15
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2012-04-09

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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
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-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24

Similar Registrations

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1422634	MEDLINE INDUSTRIES, LP (Northpoint Services)	Waukegan, IL, US
1713468	ICU MEDICAL, INC	Salt Lake City, UT, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1423395. Last updated year: 2026. Please use registration number 1423395 when referencing this establishment in official correspondence.