Data / Medical devices / Oxygenator, Long Term Support Greater Than 6 Hours
Oxygenator, Long Term Support Greater Than 6 Hours (BYS): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Oxygenator, Long Term Support Greater Than 6 Hours (product code BYS, Class 2, 21 CFR 870.4100). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on October 4, 2023, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- BYS
- Device class
- 2
- Regulation
- 870.4100
- Medical specialty
- Cardiovascular
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| Germany | 3 |
| United States | 1 |
| Mexico | 1 |
Makers of Oxygenator, Long Term Support Greater Than 6 Hours
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 |
|---|---|---|---|---|---|---|---|---|
| MC3, Inc. | Dexter, MI, United States | Manufacturer, Manufacturer for export, Specification developer | 2 | October 4, 2023 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenios AG | Stolberg North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenios AG | Reutlingen Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenios AG | Heilbronn Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 4, 2023. 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.