Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Whole-body plethysmograph FDA UDI
- Device Name
- Accessory intended use EUDAMEDFPV housing clamp FDA UDI
- Model / Reference
- V-707175 EUDAMEDV-707392 EUDAMEDFDA UDI
- Description
- FPV housing clamp FDA UDI
Identifiers
- Catalog Number
- V-707392 FDA UDI
- Primary DI / UDI-DI
- 14250892905430 EUDAMED14250892903726 EUDAMEDFDA UDI
- Basic UDI-DI
- 42508929011871QH EUDAMED
- 510(k) Number
- K190853 FDA UDI
- FDA Product Code
- BZC FDA UDIJEH FDA UDIBTY FDA UDI
- EMDN Code
- Z12159085 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Whole-body plethysmograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1880 FDA UDI868.1760 FDA UDI868.1890 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 intended use 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 | 42508929011871QH | 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 (3)
- EUDAMED 879e0136-04ed-4831-9c64-b53ac51463a8 61 fields · synced Jul 8, 2026
- EUDAMED a24d3aab-b711-4c83-8a88-372ec3e62b4b 61 fields · synced May 19, 2026
- FDA UDI 435e5ef3-56d4-4416-af31-833b9db54d98 37 fields · synced May 30, 2026