Negative-pressure wound therapy system pump

Risk Class

Class IIa

Product Type

Single Device Product

ARTG Category

General

Start Date

February 29, 2024

Effective Date

February 29, 2024

Name

KCI Medical Australia Pty Ltd

Name

KCI USA Inc

Country

United States of America

Address

12930 IH 10 West, San Antonio, TX, 78249

The V.A.C. Therapy unit is a component of the V.A.C. Therapy System. The V.A.C. Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. When used on open wounds, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.