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
- [email protected]
- Phone
- 224 2706181
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2013-12-20 |
| Set, Blood Transfusion | BRZ | Class 2 | General Hospital | No | 1997-07-10 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2007-07-05 |
| System, Hemodialysis, Remote Accessories | MON | Class 1 | Gastroenterology, Urology | No | 2017-12-31 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2007-12-03 |
| Adaptor, Ureteral Catheter | EYI | Class 1 | Gastroenterology, Urology | No | 2026-01-20 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2007-12-03 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2007-12-03 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2025-03-05 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 1991-12-31 |
| System/Device, Pharmacy Compounding | NEP | Class 2 | General Hospital | No | 2007-07-05 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2023-04-19 |
| System, Processing For Frozen Blood | KSW | Class 2 | Hematology | No | 2010-11-22 |
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)