Data / Medical devices / United States / Baxter Healthcare Corporation
Baxter Healthcare Corporation: FDA-registered device maker in Cleveland, MS, United States, 2 510(k) clearances
Baxter Healthcare Corporation is registered with the FDA (registration 1019003) in Cleveland, MS, United States. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 19, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1019003
- Address
- 911 North Davis, Cleveland, MS, United States, 38732
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (1417572)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 31, 1992
- Registered through
- 2026
- Brand names listed
- Baxject II Hi-Flow Needleless Transfer Device, Baxject II Needleless Transfer Device, DUPLOJECT EASY-PREP SYSTEM, Evacuated Container, FLOWEASE [SUBCUTANEOUS] INFUSION SET, Galaxy, Glycerolyte 57 Solution, MINIBAG PLUS CONTAINER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Set, Administration, For Peritoneal Dialysis, Disposable | KDJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Supplies, Blood-Bank | KSS | 1 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| System, Processing For Frozen Blood | KSW | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2014 | K142600 | VIAL-MATE Adaptor | LHI | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| June 24, 2002 | K020666 | DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML | FMF | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Set, I.V. Fluid Transfer
- All makers of Set, Administration, For Peritoneal Dialysis, Disposable
- All makers of Accessories, Catheter
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Syringe, Piston
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Updated November 19, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.