Gibeck IPN916673
Gibeck IPN916673 (RGH940U) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K964382 on 15 Apr 1997 and listed in FDA GUDID since 26 Oct 2020 (UDI-DI 14026704717733), 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 | Number14026704717733 | Date26 Oct 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK964382 | Date15 Apr 1997 | StatusActive |
Official records
- AccessGUDID record 14026704717733
- FDA 510(k) database K964382
Across registries
- FDA 510(k) K964382 decided 15 Apr 1997 Active
- FDA GUDID UDI-DI 14026704717733 listed 26 Oct 2020 Listed
Timeline
- Cleared FDA 510(k) K964382
- Listed FDA GUDID 14026704717733
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gibeck
- Generic name
- Heat/moisture exchanger/microbial medical gas filter
- Model / Ref / Catalog
- IPN916673, RGH940U
- Primary DI / UDI-DI
- 14026704717733
- 510(k) Number
- FDA product code
- CAH
- GMDN term
- Heat/moisture exchanger/microbial medical gas filter
- Device class
- Class II
- Regulation number
- 868.5260
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Heat/moisture exchanger/microbial medical gas filter.