Adims 1.0
Adims 1.0 is a Class II device made by Csl Plasma, Inc., listed under FDA premarket submission BK190430 and listed in FDA GUDID since 10 Jan 2022 (UDI-DI 00860007397615), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK190430
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860007397615 | Date10 Jan 2022 | StatusListed |
| United States | FDA 510(k) | NumberBK190430 | Date— | StatusActive |
Official records
- AccessGUDID record 00860007397615
Across registries
- FDA premarket submission BK190430 Active
- FDA GUDID UDI-DI 00860007397615 listed 10 Jan 2022 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Adims
- Generic name
- Blood bank information system application software
- Model / reference
- 1.0
- Primary DI / UDI-DI
- 00860007397615
- FDA product code
- MMH
- GMDN term
- Blood bank information system application software
- Device class
- Class II
- Regulation number
- 864.9165
- GUDID distribution status
- In Commercial Distribution