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Activ.a.c. ™

FDA UDI

Class II (US FDA UDI)

by Kci Usa, Inc.

Identity

Trade Name
ACTIV.A.C. ™ FDA UDI
Generic Name
Negative-pressure wound therapy system, battery-powered, reusable FDA UDI
Device Name
Activac Therapy System FDA UDI
Model / Reference
340000 FDA UDI
Description
Activac Therapy System FDA UDI

Identifiers

Primary DI / UDI-DI
00878237001813 FDA UDI
510(k) Number
K063692 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Negative-pressure wound therapy system, battery-powered, reusable 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Negative-pressure wound therapy system, battery-powered, reusable

Activ.a.c. ™ by Kci Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system, battery-powered, reusable.

Cleared under the same submission

K063692 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kci Usa, Inc.

Sources (1)

  • FDA UDI a905de3a-0ec6-46df-af45-e11119475ce3 34 fields · synced May 30, 2026