AmerisourceBergen 10545
by Bp Pharmaceuticals Laboratories Unlimited Company
AmerisourceBergen 10545 is a Class II device made by Bp Pharmaceuticals Laboratories Unlimited Company, cleared under FDA 510(k) K770463 on 23 Mar 1977 and listed in FDA GUDID since 25 Feb 2021 (UDI-DI 00368001105453), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00368001105453 | Date25 Feb 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK770463 | Date23 Mar 1977 | StatusActive |
Official records
- AccessGUDID record 00368001105453
- FDA 510(k) database K770463
Across registries
- FDA 510(k) K770463 decided 23 Mar 1977 Active
- FDA GUDID UDI-DI 00368001105453 listed 25 Feb 2021 Listed
Timeline
- Cleared FDA 510(k) K770463
- Listed FDA GUDID 00368001105453
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AmerisourceBergen
- Generic name
- Surgical/medical face mask, non-antimicrobial, single-use
- Model / reference
- 10545
- Primary DI / UDI-DI
- 00368001105453
- 510(k) Number
- FDA product code
- FXX
- GMDN term
- Surgical/medical face mask, non-antimicrobial, single-use
- Device class
- Class II
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
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