FDA Registration Active 🇲🇹 Malta

Baxter Limited

Reg #: 3003704957 · FEI: 3003704957 · Expires 2026
Products
13
Proprietary Names
96
Establishment Types
2
Classifications
13

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Registration Details

Registration Name
Baxter Limited
Registration Number
3003704957
FEI Number
3003704957
Status
Active
Expiry Year
2026
Initial Importer
No
Address
A47 INDUSTRIAL (ESTATE) MRS3000
City
Marsa
Country
MT

Regulatory Submissions

510(k) Number
K132734

Owner / Operator

Firm Name
BAXTER HEALTHCARE CORPORATION
Operator Number
1417572
Address
One Baxter Parkway
City
Deerfield
State
IL
Postal Code
60015
Country
US
Correspondent
Maha Nolasco

US Agent

Business Name
BAXTER HEALTHCARE CORPORATION
Contact Name
Maha Nolasco
Address
25212 W. IL Route 120, RLT-04
City
Round Lake
State
IL
ZIP
60073
Country
US
Phone
224 2706181

Products

Device Name Product Code
Set, Administration, Intravascular FPA
Set, Blood Transfusion BRZ
Set, I.V. Fluid Transfer LHI
System, Hemodialysis, Remote Accessories MON
Syringe, Piston FMF
Adaptor, Ureteral Catheter EYI
Arthroscope HRX
System, Irrigation, Urological LJH
Filter, Infusion Line FPB
Dispenser, Liquid Medication KYX
System/Device, Pharmacy Compounding NEP
Stopcock, I.V. Set FMG
System, Processing For Frozen Blood KSW

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 Duo-Vent Continu-Flo Control-A-Flo I.V. Administration Set with Control-A-Flo Regulator Blood Administration Sets Solution Sets w/Capless Luer Valve Buretrol Solution Set w/1.2 Micron Air Eliminating Filter Sterile Luer Lock-to-Urethral Tip Adapter Sterile Luer Lock-to-Catheter Tip Adapter 3 Port Adapter Interlink System T Connector Ext Se TUR Irrigation Set Cystoscopy Irrigation Set Arthroscopic Irrigation Set Uromatic Arthromatic Solutions Administration Sets with 0.2 Micron Filter Intravascular Extension Sets and Accessories Dual Luer Lock Cap Solution Set with 1.2 Micron Air Eliminating Filter Micro-Volume MICRO-VOLUME Extension Set Flo-Gard Colleague Low Plasticizer Administration Sets Solution Set Secondary Medication Set ContinuFlo Solution Set Radiation Sterilized Extension Sets Mini-Infuser Interlink Universal Vial Adapter NEOTHRIVE Oral Liquid Dispenser EXACTAMED KWIK VIAL ADAPTACAP EXACTAMED Oral Dispenser Oral Liquid Bottle Adapter Solution Sets, Extension Sets 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 Buretrol Solution Sets Solution Administration Sets Glycerolyte 57 Solution Processing Solution Nitroglycerin Set with DUO-VENT Spike Clearlink Luer Activated Valve Interlink System Sub-Q-Set Subcutaneous Infusion Set Sub-Q-Set Intravascular Extension Set (Light Resistant Extension Set) 3 Lead Ext w/2 Interlink Inject Sit Interlink System T-Connector ExtSet Paclitaxel Sets Blood Administration Set REPEATER PUMP Tube Sets and Connectors Dispencing Pins RAPIDFILL VIAL-MATE Reconstitution Device Viaflex Vial-Mate PCA Syringe Sets Stopcock and I.V. Solution Administration Sets with Stopcocks Solution Set for Epidural Use

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)