Identity
- Trade Name
- Oxygen Enrichment Kit EUDAMEDFDA UDI
- Generic Name
- Oxygen/air breathing gas mixer, hospital FDA UDI
- Device Name
- Ventway Sparrow Oxygen Enrichment Kit EUDAMED
- Model / Reference
- VWSP-304 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017096933 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290017096VentwayEKYP 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
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Pulmonary function analysis system, adult
Oxygen Enrichment Kit by Inovytec Medical Solutions Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7290017096VentwayEKYP | 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 228bb785-4d71-4c5d-bcb6-e3438a0855b7 61 fields · synced Jun 18, 2026
- FDA UDI 8771cb52-d317-401d-bf6a-d363397c5a58 34 fields · synced May 30, 2026