Mediplus A202PFX-D
Mediplus A202PFX-D is a capnography oxygen mask (FDA Class II; FDA product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) made by Mediplus, Ltd., cleared under FDA 510(k) K131339 on 25 Nov 2013 and listed in FDA GUDID since 29 Jan 2019 (UDI-DI 05055140703934), active as of 22 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 | Number05055140703934 | Date29 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131339 | Date25 Nov 2013 | StatusActive |
Official records
- AccessGUDID record 05055140703934
- FDA 510(k) database K131339
Across registries
- FDA 510(k) K131339 decided 25 Nov 2013 Active
- FDA GUDID UDI-DI 05055140703934 listed 29 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K131339
- Listed FDA GUDID 05055140703934
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mediplus
- Generic name
- Capnography oxygen mask
- Model / reference
- A202PFX-D
- Primary DI / UDI-DI
- 05055140703934
- 510(k) Number
- FDA product code
- CCK
- GMDN term
- Capnography oxygen mask
- Device class
- Class II
- Regulation number
- 868.1400
- GUDID distribution status
- In Commercial Distribution
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