Vyaire 36-PSA1800
Vyaire 36-PSA1800 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 28 May 2019 (UDI-DI 14250892904129), 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 | Number14250892904129 | Date28 May 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK950197 | Date17 Oct 1996 | StatusActive |
Official records
- AccessGUDID record 14250892904129
- FDA 510(k) database K950197
Across registries
- FDA 510(k) K950197 decided 17 Oct 1996 Active
- FDA GUDID UDI-DI 14250892904129 listed 28 May 2019 Listed
Timeline
- Cleared FDA 510(k) K950197
- Listed FDA GUDID 14250892904129
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- Withdrawn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-PSA1800
- Primary DI / UDI-DI
- 14250892904129
- 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
Similar devices
Other devices filed under FDA product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase).
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- ToxCO by Bedfont Scientific Ltd
- CD-102 CARBON DIOXIDE ANALYZER/RECOR by Instrumentarium Corp.
- TRAPPER by FIM MEDICAL
- CO/CMD-1 by Spirometrics, Inc.
- VITALOGRAPH - BREATHCO MONITOR by Mcneill Intl., Inc.