Data / Medical devices / Tubes, Vacuum Sample, With Anticoagulant
Tubes, Vacuum Sample, With Anticoagulant (GIM): 15 FDA-registered makers in 5 countries
15 establishments in 5 countries are registered with the FDA to make Tubes, Vacuum Sample, With Anticoagulant (product code GIM, Class 2, 21 CFR 862.1675). 15 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 39 510(k) clearances under this code, the latest on October 31, 2024, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GIM
- Device class
- 2
- Regulation
- 862.1675
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| United Kingdom | 2 |
| Mexico | 1 |
| Brazil | 1 |
| Austria | 1 |
Makers of Tubes, Vacuum Sample, With Anticoagulant
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 |
|---|---|---|---|---|---|---|---|---|
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 8 | July 10, 1992 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Norfolk, NE, United States | Manufacturer | 6 | January 8, 1992 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 2 | November 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Quiroproductos de Cuauhtemoc S. De R.L. de C.V. | Cuauhtemoc Chihuahua, Mexico | Manufacturer | 2 | July 10, 1992 | 0 | 0 | 0 | api.fda.gov |
| BD Puerto Rico LLC | Juncos, PR, United States | Manufacturer | 1 | November 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Broken Bow, NE, United States | Manufacturer | 1 | August 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Company (BD) | Plymouth Devon, United Kingdom | Manufacturer | 1 | August 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Caltag Medsystems Ltd | Buckingham Buckinghamshire, United Kingdom | Manufacturer | 1 | June 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 1 | November 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Greiner Bio One Brasil Produtos Medicos Hospitalar | AMERICANA Sao Paulo, Brazil | Manufacturer | 1 | May 2, 1997 | 0 | 0 | 0 | api.fda.gov |
| Greiner Bio-One GMBH | KREMSMUENSTER Oberosterreich, Austria | Manufacturer, Specification developer | 1 | May 2, 1997 | 0 | 0 | 0 | api.fda.gov |
| Greiner Bio-One North America, Inc. | Monroe, NC, United States | Manufacturer | 1 | May 2, 1997 | 0 | 7 | 0 | api.fda.gov |
| Porex Corporation | Fairburn, GA, United States | Manufacturer | 1 | November 2, 1977 | 0 | 0 | 0 | api.fda.gov |
| Streck LLC | La Vista, NE, United States | Manufacturer | 1 | July 31, 2008 | 0 | 1 | 0 | api.fda.gov |
| Streck LLC | La Vista, NE, United States | Manufacturer | 1 | July 31, 2008 | 0 | 0 | 0 | api.fda.gov |
Updated October 31, 2024. 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.