Medex 292004
Medex 292004 is an endotracheal tube cuff inflator (FDA Class II; FDA product code BSK, Cuff, tracheal tube, inflatable) made by ICU Medical, Inc., cleared under FDA 510(k) K833327 on 28 Nov 1983 and listed in FDA GUDID since 29 Jul 2015 (UDI-DI 10351688517173), 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 | Number10351688517173 | Date29 Jul 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK833327 | Date28 Nov 1983 | StatusActive |
Official records
- AccessGUDID record 10351688517173
- FDA 510(k) database K833327
Across registries
- FDA 510(k) K833327 decided 28 Nov 1983 Active
- FDA GUDID UDI-DI 10351688517173 listed 29 Jul 2015 Listed
Timeline
- Cleared FDA 510(k) K833327
- Listed FDA GUDID 10351688517173
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medex
- Generic name
- Endotracheal tube cuff inflator
- Model / reference
- 292004
- Primary DI / UDI-DI
- 10351688517173
- 510(k) Number
- FDA product code
- BSK
- GMDN term
- Endotracheal tube cuff inflator
- Device class
- Class II
- Regulation number
- 868.5750
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code BSK (Cuff, tracheal tube, inflatable).
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- CUFF BARO GUARD OR CBG ABBREVIATED by Nelson Engineering, Inc.
- IntelliCuff by Hamilton Medical AG
- CUFFALERT by SunMed
- RESPIRONICS PR VALVE by Respironics, Inc.
- CUFFCHECK by Dhd Medical Products Div. Diemolding Corp.
- Accucuff Cuff Pressure Indicator by Tianjin Medis Medical Device Co., Ltd.
- Puritan Bennett Cuff Pressure Manager by Covidien llc