Identity
- Trade Name
- Reprocessed Venaflow Calf Cuff, Large, 1 Pair FDA UDI
- Generic Name
- Single-chamber venous compression system garment, reprocessed FDA UDI
- Model / Reference
- 3012 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B39030121 FDA UDI
- 510(k) Number
- K052691 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Single-chamber venous compression system garment, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Reprocessed Venaflow Calf Cuff, Large, 1 Pair by Suretek Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Suretek Medical
Sources (1)
- FDA UDI e5935cb1-9f1b-48ea-adf0-e0942784a71a 34 fields · synced May 30, 2026