Data / Medical devices / Arterial Blood Sampling Kit / United States
FDA-registered makers of Arterial Blood Sampling Kit in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Arterial Blood Sampling Kit (product code CBT). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Arterial Blood Sampling Kit
- Product code
- CBT
- Country
- United States
Makers of Arterial Blood Sampling Kit in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 3 | August 1, 2007 | 0 | 0 | 0 | api.fda.gov |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer, Specification developer | 3 | December 5, 1994 | 0 | 1 | 0 | api.fda.gov |
| Customed, Inc. | Fajardo, PR, United States | Manufacturer | 1 | July 14, 1993 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 1 | March 15, 2007 | 0 | 1 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | March 17, 1997 | 0 | 0 | 0 | api.fda.gov |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icu Medical, Inc | Salt Lake City, UT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Laredo | Laredo, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Opti Medical Systems Inc. | Roswell, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vygon Usa | Lansdale, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vygon MFG | Dover, NH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.