Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Carbon monoxide breath analyser FDA UDI
- Device Name
- Mouthpiece Adaptor FDA UDI
- Model / Reference
- 36-PSA1800 FDA UDI
- Description
- Mouthpiece Adaptor FDA UDI
Identifiers
- Catalog Number
- 36-PSA1800 FDA UDI
- Primary DI / UDI-DI
- 14250892904129 FDA UDI
- 510(k) Number
- K950197 FDA UDI
- FDA Product Code
- CCJ FDA UDI
- GMDN Term
- Carbon monoxide breath analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1430 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carbon monoxide breath analyser
Vyaire by Jaeger Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K950197 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jaeger Medical GmbH
Sources (1)
- FDA UDI fe615b0d-a176-423d-9f84-6224bc6fd69f 37 fields · synced Jun 8, 2026