Identity
- Trade Name
- 3M™ Vac® FDA UDI
- Generic Name
- Irrigation negative-pressure wound therapy unit FDA UDI
- Device Name
- 3M™ Vac® Ulta Therapy Unit CAPULTDEV01/US FDA UDI
- Model / Reference
- CAPULTDEV01/US FDA UDI
- Description
- 3M™ Vac® Ulta Therapy Unit CAPULTDEV01/US FDA UDI
Identifiers
- Catalog Number
- CAPULTDEV01/US FDA UDI
- Primary DI / UDI-DI
- 00849554008366 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Irrigation negative-pressure wound therapy unit 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
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
MR Unsafe FDA UDI
Category: Irrigation negative-pressure wound therapy unit
3M™ Vac® 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 unit.
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- V.A.C.ULTA™ — KCI USA, INC. · Class II
- 3M™ Vac® — KCI USA, INC. · Class II
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 17b7ab14-d3e0-4033-b41f-e56b6a640971 35 fields · synced May 30, 2026