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Negative-pressure wound therapy system pump - ARTG 442989

Access comprehensive regulatory information for Negative-pressure wound therapy system pump in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 442989 and sponsored by KCI Medical Australia Pty Ltd, manufactured by KCI USA Inc in United States of America. The device registration started on February 29, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class IIa
ARTG 442989
Class IIa
Negative-pressure wound therapy system pump
ARTG ID: 442989
Good Name: KCI Medical Australia Pty Ltd - Negative-pressure wound therapy system pump
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Intended Purpose

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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
442989
Start Date
February 29, 2024
Effective Date
February 29, 2024
Manufacturer
Country
United States of America
Address
12930 IH 10 West, San Antonio, TX, 78249