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Accessory patient gas pathway expiratory only
EUDAMEDFDA UDIClass I (EU MDR)
Ref 36-ASS1221
Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Airway pressure monitor, powered FDA UDI
- Device Name
- Accessory patient gas pathway expiratory only EUDAMEDEXPIRATORY PRESSURE VALVE FDA UDI
- Model / Reference
- 36-ASS1221 EUDAMEDFDA UDI
- Description
- EXPIRATORY PRESSURE VALVE FDA UDI
Identifiers
- Catalog Number
- 36-ASS1221 FDA UDI
- Primary DI / UDI-DI
- 14250892904112 EUDAMEDFDA UDI
- Basic UDI-DI
- 42508929011861QE EUDAMED
- 510(k) Number
- K940375 FDA UDI
- FDA Product Code
- CAP FDA UDI
- EMDN Code
- Z12159085 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Airway pressure monitor, powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2600 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 875e8369-bdb1-4688-af9b-0385293279d1 61 fields · synced Jun 18, 2026
- FDA UDI d3ed4fa9-b81f-4833-b66c-6ab47e9982e9 37 fields · synced May 30, 2026