Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2025695

FEI Number

2025695

Entity Name

BAXTER HEALTHCARE CORPORATION

City/State/Country

IRVINE, CA, US

Establishment Address

17511 Armstrong Ave, IRVINE, CA 92614, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Infusor Patients Control Module, 2 mL Multirate Infusor LV Multirate Infusor SV Baxter Pain Mate Pain Mgt System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2024-09-23
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2007-12-03

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 Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2012	Smiths Medical ASD, Inc.	2	Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion.

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2016493	CareFusion 303, INC.	SAN DIEGO, CA, US
3010381606	EMSERE BV	Leiden Zuid-Holland, NL
3003879246	CareFusion 303, INC	San Diego, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025695. Last updated year: 2026. Please use registration number 2025695 when referencing this establishment in official correspondence.