Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014342658

FEI Number

3014342658

Entity Name

Microtek Medical LLC

City/State/Country

Northfield, IL, US

Establishment Address

3 Lakes Dr, Northfield, IL 60093, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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 Microtek Microtek Transfer Bottle Collection Bottle Venodyne PUMP Compression Limb Sleeve Stryker Ascent Microtek Microtek Medline Light Handle Cover Microtek Remote Control Drape 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 Microtek Medline Silicone Bulb Evacuator for Closed Wound Drainage Medline Evacuator Kit Wound Evac Microtek Medline Wound Drain Kit Hush-Slush Consoles Fluid Warming and Surgical Slush IntraTemp Fluid Warming System CoreTemp Surgical Solution Warming System ORS Solution Warmers Ecolab Fluid Warmer Titan Series IntraTemp ThermaBasin Safety frames / lens Microtek Drape Armour

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-09-17
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-10-30
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2024-10-30
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-10-30
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2018-03-22
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-10-30
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2016-01-13
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-25
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-10-30
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2014-10-16
LHC	Warmer, Irrigation Solution	Physical Medicine	Class 1	890.5950	2024-10-09
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2015-01-13

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
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0003-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0004-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Similar Registrations

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3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014342658. Last updated year: 2026. Please use registration number 3014342658 when referencing this establishment in official correspondence.