Identity
- Trade Name
- ACTIV.A.C.™ FDA UDI
- Generic Name
- Negative-pressure wound therapy system canister FDA UDI
- Device Name
- 300 ml Canister (with Gel) for Activac Therapy System Fluid Path Sterile FDA UDI
- Model / Reference
- M8275058/5 M8275058/10 FDA UDI
- Description
- 300 ml Canister (with Gel) for Activac Therapy System Fluid Path Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849554001992 FDA UDI
- 510(k) Number
- K063692 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system canister 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
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
Category: Negative-pressure wound therapy system canister
Activ.a.c.™ by Kci Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K063692 also covers:
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 a1e29831-94ed-48de-ac1c-add7b26844f8 34 fields · synced Jun 8, 2026