Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1019003

FEI Number

1019003

Entity Name

BAXTER HEALTHCARE CORPORATION

City/State/Country

CLEVELAND, MS, US

Establishment Address

911 NORTH DAVIS, CLEVELAND, MS 38732, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142600

PMA Number

N/A

All Registered Proprietary Names

MiniCap with Povidone-Iodine Solution Malleable Applicator Tip DUPLOJECT EASY-PREP SYSTEM Baxject II Needleless Transfer Device Galaxy Mini-Bag Plus MINIBAG PLUS CONTAINER VIAL-MATE Reconstitution Device Viaflex Vial-Mate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2016-01-11
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	1992-12-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2007-12-12
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	1994-12-27
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2015-02-09

Official Correspondent

Maha Nolasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3019257308	VIDEOMED SRL	LIMENA Padova, IT
1314492	Baxter Healthcare Corporation	MEDINA, NY, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-05	Fresenius Medical Care North America	2	Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1019003. Last updated year: 2026. Please use registration number 1019003 when referencing this establishment in official correspondence.