Data / Medical devices / Arterial Blood Sampling Kit
Arterial Blood Sampling Kit (CBT): 21 FDA-registered makers in 6 countries
21 establishments in 6 countries are registered with the FDA to make Arterial Blood Sampling Kit (product code CBT, Class 1, 21 CFR 868.1100). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 58 510(k) clearances under this code, the latest on August 1, 2007, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CBT
- Device class
- 1
- Regulation
- 868.1100
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Mexico | 5 |
| Dominican Republic | 1 |
| China | 1 |
| India | 1 |
| Ireland | 1 |
Makers of Arterial Blood Sampling Kit
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 2 | August 1, 2007 | 0 | 0 | 0 | api.fda.gov |
| Customed, Inc. | Fajardo, PR, United States | Manufacturer | 1 | July 14, 1993 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 1 | November 20, 1995 | 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 | |
| Caribbean Custom Mold Inc | Santo Domingo, Dominican Republic | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hantech Medical Device Co., Ltd. | Cixi Zhejiang, China | 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 | |
| SPM Medicare Pvt, Ltd. | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Utah Medical Products, Ltd. | ATHLONE CO. Leinster, Ireland | Contract manufacturer | 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 | |
| Westmed Javid de Mexico, S.A. de C.V. | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 1, 2007. 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.