Maxx Bmc Mxbmc-60
Maxx Bmc Mxbmc-60 is a Class II device made by Royal Biologics Inc., listed under FDA premarket submission BK210632 and listed in FDA GUDID since 3 Jun 2022 (UDI-DI 00850014593391), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK210632
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850014593391 | Date3 Jun 2022 | StatusListed |
| United States | FDA 510(k) | NumberBK210632 | Date— | StatusActive |
Official records
- AccessGUDID record 00850014593391
Across registries
- FDA premarket submission BK210632 Active
- FDA GUDID UDI-DI 00850014593391 listed 3 Jun 2022 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Maxx Bmc
- Generic name
- Haematological concentrate system preparation kit, platelet concentration
- Model / Ref / Catalog
- MXBMC-60
- Primary DI / UDI-DI
- 00850014593391
- FDA product code
- ORG
- GMDN term
- Haematological concentrate system preparation kit, platelet concentration
- Device class
- Class II
- Regulation number
- 864.9245
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 60 Milliliter
Similar devices in this category
Other devices filed under Haematological concentrate system preparation kit, platelet concentration.