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Accessory Patient gas pathway inspiratory and expiratory
EUDAMEDFDA UDIClass I (EU MDR)
Ref 36-ASS1307
Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Airway pressure monitor, powered FDA UDI
- Device Name
- Accessory Patient gas pathway inspiratory and expiratory EUDAMEDMicrogard II filter adapter for RPM FDA UDI
- Model / Reference
- 36-ASS1307 EUDAMEDFDA UDI
- Description
- Microgard II filter adapter for RPM FDA UDI
Identifiers
- Catalog Number
- 36-ASS1307 FDA UDI
- Primary DI / UDI-DI
- 14250892905775 EUDAMEDFDA UDI
- Basic UDI-DI
- 42508929011841Q8 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 inspiratory and expiratory by Jaeger Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 42508929011841Q8 | 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 3c3b84c7-a5e4-4fb7-a125-72dbfe44bdd4 61 fields · synced Jul 15, 2026
- FDA UDI 9f0cad2c-b8cd-4b7d-ab22-799fad3dd042 37 fields · synced May 29, 2026