Vyaire 36-MC02-STK
Vyaire 36-MC02-STK is a Class II device made by Jaeger Medical GmbH, cleared under FDA 510(k) K950197 on 17 Oct 1996 and listed in FDA GUDID since 19 Mar 2019 (UDI-DI 54250892905506), 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 | Number54250892905506 | Date19 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK950197 | Date17 Oct 1996 | StatusActive |
Official records
- AccessGUDID record 54250892905506
- FDA 510(k) database K950197
Across registries
- FDA 510(k) K950197 decided 17 Oct 1996 Active
- FDA GUDID UDI-DI 54250892905506 listed 19 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K950197
- Listed FDA GUDID 54250892905506
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vyaire
- Generic name
- Carbon monoxide breath analyser
- Model / Ref / Catalog
- 36-MC02-STK
- Primary DI / UDI-DI
- 54250892905506
- 510(k) Number
- FDA product code
- CCJ
- GMDN term
- Carbon monoxide breath analyser
- Device class
- Class II
- Regulation number
- 868.1430
- GUDID distribution status
- In Commercial Distribution
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