Identity
- Trade Name
- Smart-V-Link FDA UDI
- Generic Name
- Ultrasound imaging system application software FDA UDI
- Device Name
- Vascular documentation software FDA UDI
- Model / Reference
- Smart-V-Link FDA UDI
- Description
- Vascular documentation software FDA UDI
Identifiers
- Catalog Number
- Smart-V-Link FDA UDI
- Primary DI / UDI-DI
- 00894912002777 FDA UDI
- 510(k) Number
- K963274 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Ultrasound imaging system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultrasound imaging system application software
Smart-V-Link by Koven Technology, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Koven Technology, Inc.
Sources (1)
- FDA UDI 19284a66-2167-40cc-a83c-298e6ac5a6cb 36 fields · synced Jun 9, 2026