Data / Medical devices / Set, Blood Transfusion
Set, Blood Transfusion (BRZ): 14 FDA-registered makers in 6 countries
14 establishments in 6 countries are registered with the FDA to make Set, Blood Transfusion (product code BRZ, Class 2, 21 CFR 880.5440). 13 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on November 17, 2022, and lists 5 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- BRZ
- Device class
- 2
- Regulation
- 880.5440
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Dominican Republic | 2 |
| France | 2 |
| Malta | 1 |
| Costa Rica | 1 |
| Mexico | 1 |
Makers of Set, Blood Transfusion
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 |
|---|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 3 | November 17, 2022 | 0 | 1 | 0 | api.fda.gov |
| Baxter Healthcare, S.A. | Haina San Cristobal, Dominican Republic | Manufacturer | 3 | November 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Baxter Limited | Marsa, Malta | Specification developer | 3 | November 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Arteriocyte Medical Systems, Inc. | Hopkinton, MA, United States | Manufacturer | 1 | October 4, 2013 | 0 | 0 | 0 | api.fda.gov |
| Baxter Productos Medicos, Ltda. | 1-7052 Cartago, Costa Rica | Manufacturer | 1 | November 17, 1999 | 0 | 0 | 0 | api.fda.gov |
| Carefusion | San Diego, CA, United States | Specification developer | 1 | April 1, 2005 | 0 | 0 | 0 | api.fda.gov |
| Charter Medical, LLC | Winston Salem, NC, United States | Contract manufacturer, Manufacturer | 1 | August 15, 2000 | 0 | 0 | 0 | api.fda.gov |
| Douglas Medical Products, Inc | Mundelein, IL, United States | Complaint file establishment, Specification developer | 1 | June 4, 1992 | 0 | 0 | 0 | api.fda.gov |
| Ecomed Solutions, LLC | Lindenhurst, IL, United States | Complaint file establishment, Specification developer | 1 | April 10, 2009 | 0 | 0 | 0 | api.fda.gov |
| Fenwal International, Inc. | HAINA San Cristobal, Dominican Republic | Manufacturer | 1 | March 3, 2008 | 0 | 0 | 0 | api.fda.gov |
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 1 | March 3, 2008 | 0 | 0 | 0 | api.fda.gov |
| Sap | Saint Saulve Hauts-de-France, France | Manufacturer | 1 | May 3, 1985 | 0 | 0 | 0 | api.fda.gov |
| Vygon S A | ECOUEN 95440 Val-d'Oise, France | Manufacturer | 1 | May 3, 1985 | 0 | 0 | 0 | api.fda.gov |
| SISTEMAS MEDICOS ALARIS, S.A De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 17, 2022. 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.