CompoMat G5 9025561
CompoMat G5 9025561 is a Class I device made by Fresenius Kabi, listed under FDA premarket submission BK110012 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04086000860475), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK110012
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04086000860475 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberBK110012 | Date— | StatusActive |
Official records
- AccessGUDID record 04086000860475
Across registries
- FDA premarket submission BK110012 Active
- FDA GUDID UDI-DI 04086000860475 listed 16 Sep 2016 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CompoMat G5
- Generic name
- Blood component separator, automated
- Model / Ref / Catalog
- 9025561
- Primary DI / UDI-DI
- 04086000860475
- FDA product code
- KSS
- GMDN term
- Blood component separator, automated
- Device class
- Class I
- Regulation number
- 864.9050
- GUDID distribution status
- In Commercial Distribution
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