Identity
- Trade Name
- Ventway Sparrow Robust Ventilator MRI Compatible FDA UDI
- Generic Name
- Transport electric ventilator FDA UDI
- Model / Reference
- VWSP-900MR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017096735 FDA UDI
- 510(k) Number
- K202970 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Transport electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Transport electric ventilator
Ventway Sparrow Robust Ventilator MRI Compatible by Inovytec Medical Solutions Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transport electric ventilator.
- PATIENT CIRCUITS — Zoll Medical Corporation · Class II
- Life Support Products — Allied Medical LLC · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- VENT — Zoll Medical Corporation · Class II
- PATIENT CIRCUITS — Zoll Medical Corporation · Class II
- Z Vent — Zoll Medical Corporation · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Cleared under the same submission
K202970 also covers:
- Inlet Filter - Regular — INOVYTEC MEDICAL SOLUTIONS LTD
- Patient Circuit - Adult, 2.4m, 1 pcs — INOVYTEC MEDICAL SOLUTIONS LTD
- Patient Circuit - Pediatric, 1.8m, 1 pcs, one way — INOVYTEC MEDICAL SOLUTIONS LTD
- Patient Circuit - Pediatric, 2.4m, 1 pcs — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow MRI — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow MRI Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow MRI Robust Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Robust — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Robust Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inovytec Medical Solutions Ltd
Sources (1)
- FDA UDI 9b2c0710-2e6a-496d-b7b7-0a7ba1a7e722 34 fields · synced May 31, 2026