Identity
- Trade Name
- Vcare Alpha FDA UDI
- Generic Name
- Negative-pressure wound therapy system, electric, reusable FDA UDI
- Model / Reference
- Hose Adapter Accessory kit FDA UDI
Identifiers
- Catalog Number
- ACC-HAPT FDA UDI
- Primary DI / UDI-DI
- 07290111494109 FDA UDI
- FDA Product Code
- MKY FDA UDI
- GMDN Term
- Negative-pressure wound therapy system, electric, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Negative-pressure wound therapy system, electric, reusable
Vcare Alpha by IVT Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- IVT Medical, Ltd.
Sources (1)
- FDA UDI d4a5596e-d139-4935-a875-5bcbfc217bed 33 fields · synced May 29, 2026