Gibeck IPN924728
Gibeck IPN924728 (5383) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K964719 on 21 Feb 1997 and listed in FDA GUDID since 4 Apr 2023 (UDI-DI 14026704734150), 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 | Number14026704734150 | Date4 Apr 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK964719 | Date21 Feb 1997 | StatusActive |
Official records
- AccessGUDID record 14026704734150
- FDA 510(k) database K964719
Across registries
- FDA 510(k) K964719 decided 21 Feb 1997 Active
- FDA GUDID UDI-DI 14026704734150 listed 4 Apr 2023 Listed
Recalls
-
- Terminated Z-1809-2015
The intake port may be blocked which can cause the bag to fail to fill.
Timeline
- Cleared FDA 510(k) K964719
- Recall initiated FDA recalls Z-1809-2015
- Listed FDA GUDID 14026704734150
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gibeck
- Generic name
- PEEP valve, single-use
- Model / Ref / Catalog
- IPN924728, 5383
- Primary DI / UDI-DI
- 14026704734150
- 510(k) Number
- FDA product code
- BTM
- GMDN term
- PEEP valve, single-use
- Device class
- Class II
- Regulation number
- 868.5915
- GUDID distribution status
- In Commercial Distribution