Baxter Limited

FDA Device Registration & Listing · Marsa, MT · Registration 3003704957

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003704957
FEI Number
3003704957
Entity Name
Baxter Limited
City/State/Country
Marsa, MT
Establishment Address
A47 INDUSTRIAL (ESTATE) MRS3000, Marsa --, MT
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)
Owner / Operator Contact Address
One Baxter Parkway, Deerfield, IL 60015, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connec One-Link Blood Recipient Set Clearlink Interlink FENWAL BLOOD RECIPIENT SET Intravascular Administration Sets Clearlink System Solution Set Bard Epidural Spike Tubing Set CHEMO-AIDE DISPENSING PIN Sterile Bag PrisMax Non-DEHP IV Fat Emulsion Administration Sets Solution Administration Set Interlink Clearlink Duo-Vent Continu-Flo Continu-Flo Clearlink Interlink Control-A-Flo I.V. Administration Set with Control-A-Flo Regulator Blood Administration Sets Solution Sets w/Capless Luer Valve Duo-Vent Clearlink Control-A-Flo Continu-Flo Buretrol Interlink Solution Set w/1.2 Micron Air Eliminating Filter Interlink Clearlink Sterile Luer Lock-to-Urethral Tip Adapter Sterile Luer Lock-to-Catheter Tip Adapter Clearlink 3 Port Adapter Interlink System T Connector Ext Se Continu-Flo Interlink TUR Irrigation Set Cystoscopy Irrigation Set Arthroscopic Irrigation Set Interlink Uromatic Arthromatic Duo-Vent Clearlink Interlink Solutions Administration Sets with 0.2 Micron Filter Continu-Flo Intravascular Extension Sets and Accessories Dual Luer Lock Cap Solution Set with 1.2 Micron Air Eliminating Filter Micro-Volume Interlink MICRO-VOLUME Extension Set Clearlink System Solution Set Duo-Vent Continu-Flo Interlink Flo-Gard Colleague Low Plasticizer Administration Sets Solution Set Secondary Medication Set ContinuFlo Solution Set Control-A-Flo Duo-Vent Clearlink Continu-Flo Interlink Radiation Sterilized Extension Sets Control-A-Flo Interlink Continu-Flo Duo-Vent Buretrol Mini-Infuser Interlink Universal Vial Adapter Clearlink Interlink NEOTHRIVE Oral Liquid Dispenser EXACTAMED KWIK VIAL ADAPTACAP EXACTAMED Oral Dispenser Oral Liquid Bottle Adapter Solution Sets, Extension Sets Continu-Flo Duo-Vent MICROMIX BCR COMPOUNDER All-In-One Two Chamber Container Automix 3+3/AS Compounder System REPEATER PUMP Extension Set MICROMIX COMPOUNDER AN Abacus Luer Lock Universal Spike EM2400 Pharmacy Compounder INTELLIFILL I.V. ExactaMix Pro 2400 Display Module - Refurbished ExactaMix Pro 2400 Display Module ExactaMix Pro 1200 Display Module - Refurbished ExactaMix Pro 1200 Display Module LOGIX Transfer Set REPEATER PUMP Tube Sets AUTOMIX 3+3 COMPOUNDER Intravascular Administration Sets with Stopcock and Manifold Bard Epidural Spike Tubing Set Interlink Clearlink Buretrol Buretrol Solution Sets Solution Administration Sets Interlink Glycerolyte 57 Solution Processing Solution

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-12-20
BRZ Set, Blood Transfusion General Hospital Class 2 880.5440 1997-07-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-11-11
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2007-07-05
MON System, Hemodialysis, Remote Accessories Gastroenterology, Urology Class 1 876.5820 2017-12-31
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-09-26
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-07-30
BRZ Set, Blood Transfusion General Hospital Class 2 880.5440 2022-12-12
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-12-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
EYI Adaptor, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2026-01-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2009-11-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-04
HRX Arthroscope Orthopedic Class 2 888.1100 2007-12-03
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2007-12-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-01-11
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2025-03-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-03-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2011-02-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-06-22
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2012-03-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-05-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2009-08-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2010-07-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2007-12-03
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 1991-12-31
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-08-25
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2007-07-05
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2023-04-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-01-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
KSW System, Processing For Frozen Blood Hematology Class 2 864.9145 2010-11-22

Official Correspondent

Maha Nolasco

US Agent Details

Maha Nolasco Business: BAXTER HEALTHCARE CORPORATION Email: maha_nolasco@baxter.com Phone: (224) 2706181

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
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003704957. Last updated year: 2026. Please use registration number 3003704957 when referencing this establishment in official correspondence.
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