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Accessory patient gas pathway expiratory only
EUDAMEDFDA UDIClass I (EU MDR)
Ref 36-PSA2000
Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Carbon monoxide breath analyser FDA UDI
- Device Name
- Accessory patient gas pathway expiratory only EUDAMEDMOUTHPIECE ADAPTOR FDA UDI
- Model / Reference
- 36-PSA2000 EUDAMEDFDA UDI
- Description
- MOUTHPIECE ADAPTOR FDA UDI
Identifiers
- Catalog Number
- 36-PSA2000 FDA UDI
- Primary DI / UDI-DI
- 14250892904136 EUDAMEDFDA UDI
- Basic UDI-DI
- 42508929011861QE EUDAMED
- 510(k) Number
- K950197 FDA UDI
- FDA Product Code
- CCJ FDA UDI
- EMDN Code
- Z12159085 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Carbon monoxide breath analyser FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1430 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Accessory patient gas pathway expiratory only by Jaeger Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42508929011861QE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jaeger Medical GmbH
- EUDAMED SRN
- DE-MF-000007090
Sources (2)
- EUDAMED 453942aa-c57c-409f-8d31-30c8053abe1e 61 fields · synced Aug 1, 2026
- FDA UDI 1034c0ef-c981-43e8-ad38-9c075e7b5698 37 fields · synced May 30, 2026