Identity
- Trade Name
- V.A.C. VERAFLO™ FDA UDI
- Generic Name
- Irrigation negative-pressure wound therapy dressing FDA UDI
- Device Name
- VAC Veraflo FDA UDI
- Model / Reference
- ULTVFL05LG FDA UDI
- Description
- VAC Veraflo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849554001909 FDA UDI
- 510(k) Number
- K100657 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Irrigation negative-pressure wound therapy dressing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
MR Conditional FDA UDI
Category: Irrigation negative-pressure wound therapy dressing
V.a.c. Veraflo™ by Kci Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Irrigation negative-pressure wound therapy dressing.
- Durma+ Large Foam Dressing Kit, Large, 10" x 5.9" Foam — Dynarex Corp. · Class II
- Durma+ Small Foam Dressing Kit, Small, 4" x 2" Foam — Dynarex Corp. · Class II
- Durma+ Medium Foam Dressing Kit, Medium, 7" x 4.7" Foam — Dynarex Corp. · Class II
- 3M™ Veraflo™ — KCI USA, INC. · Class II
- 3M™ Veraflo™ — KCI USA, INC. · Class II
- 3M™ V.A.C. — KCI USA, INC. · Class II
- V.A.C. VERAT.R.A.C. DUO™ — KCI USA, INC. · Class II
- 3M™ V.A.C. Veraflo™ — KCI USA, INC. · Class II
Cleared under the same submission
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
- Kci Usa, Inc.
Sources (1)
- FDA UDI 9edea296-2210-42ee-889f-b23e7fb82305 34 fields · synced May 30, 2026