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Accessory Patient gas pathway inspiratory and expiratory
EUDAMEDFDA UDIClass I (EU MDR)
Ref V-707377
Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- Accessory Patient gas pathway inspiratory and expiratory EUDAMEDUSS Module FDA UDI
- Model / Reference
- V-707377 EUDAMEDFDA UDI
- Description
- USS Module FDA UDI
Identifiers
- Catalog Number
- V-707377 FDA UDI
- Primary DI / UDI-DI
- 34250892903188 EUDAMEDFDA UDI
- Basic UDI-DI
- 42508929011841Q8 EUDAMED
- 510(k) Number
- K181524 FDA UDI
- FDA Product Code
- BZC FDA UDI
- EMDN Code
- Z12159080 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1880 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
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 b94db2b8-4f18-497d-a854-d00e43becf53 61 fields · synced Jul 16, 2026
- FDA UDI 2ddc6d10-360e-47c1-9899-a757f59577ed 37 fields · synced May 30, 2026