Bivona AU22ES35NGA072S
Bivona AU22ES35NGA072S is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K923878 on 29 Dec 1992 and listed in FDA GUDID since 17 May 2022 (UDI-DI 15019517304794), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number15019517304794 | Date17 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK923878 | Date29 Dec 1992 | StatusActive |
Official records
- AccessGUDID record 15019517304794
- FDA 510(k) database K923878
Across registries
- FDA 510(k) K923878 decided 29 Dec 1992 Active
- FDA GUDID UDI-DI 15019517304794 listed 17 May 2022 Listed
Recalls
-
- Terminated Z-0260-2007
Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
Timeline
- Cleared FDA 510(k) K923878
- Recall initiated FDA recalls Z-0260-2007
- Listed FDA GUDID 15019517304794
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bivona
- Generic name
- Tracheostomy tube, reinforced, non-customized, single-use
- Model / reference
- AU22ES35NGA072S
- Primary DI / UDI-DI
- 15019517304794
- 510(k) Number
- FDA product code
- JOH
- GMDN term
- Tracheostomy tube, reinforced, non-customized, single-use
- Device class
- Class II
- Regulation number
- 868.5800
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional