Identity
- Trade Name
- Oxygen Mixer EUDAMEDFDA UDI
- Generic Name
- Oxygen/air breathing gas mixer, hospital FDA UDI
- Device Name
- Ventway Sparrow Oxygen Mixer EUDAMED
- Model / Reference
- VWSP-470 EUDAMEDVWSP-580 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017096926 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290017096VentwayOMZR EUDAMED
- 510(k) Number
- K202970 FDA UDI
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Oxygen/air breathing gas mixer, hospital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Romania 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Oxygen Mixer by Inovytec Medical Solutions Ltd. — Class IIa — 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 | 7290017096VentwayOMZR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Inovytec Medical Solutions Ltd.
- EUDAMED SRN
- IL-MF-000034055
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 128fe03d-7722-4cab-99df-c12a86506204 61 fields · synced Jul 27, 2026
- FDA UDI 58dc8807-5abe-40f3-9438-f646f73806c7 34 fields · synced May 30, 2026