Bird™ 10046A
Bird™ 10046A is a Class II device made by Vyaire Medical, Inc., cleared under FDA 510(k) K973646 on 7 May 1998 and listed in FDA GUDID since 29 Mar 2021 (UDI-DI 10190752174733), 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 | Number10190752174733 | Date29 Mar 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK973646 | Date7 May 1998 | StatusActive |
Official records
- AccessGUDID record 10190752174733
- FDA 510(k) database K973646
Across registries
- FDA 510(k) K973646 decided 7 May 1998 Active
- FDA GUDID UDI-DI 10190752174733 listed 29 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K973646
- Listed FDA GUDID 10190752174733
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bird™
- Generic name
- Oxygen/air breathing gas mixer, hospital
- Model / Ref / Catalog
- 10046A
- Primary DI / UDI-DI
- 10190752174733
- 510(k) Number
- FDA product code
- BZR
- GMDN term
- Oxygen/air breathing gas mixer, hospital
- Device class
- Class II
- Regulation number
- 868.5330
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Oxygen/air breathing gas mixer, hospital.