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Negative-pressure wound therapy system dressing set - ARTG 381346

Access comprehensive regulatory information for Negative-pressure wound therapy system dressing set in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 381346 and sponsored by KCI Medical Australia Pty Ltd, manufactured by KCI USA Inc in United States of America. The device registration started on December 23, 2021.

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 381346
Class IIa
Negative-pressure wound therapy system dressing set
ARTG ID: 381346
Good Name: KCI Medical Australia Pty Ltd - Negative-pressure wound therapy system dressing set
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Intended Purpose

The Gauze Procedure Pack, when used on open wounds, is intended to create an environment that promotes wound healing. The Gauze Procedure Pack is intended for use with the V.A.C. Therapy System. The V.A.C. Therapy Systems are listed below: ACTIV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. The INFOV.A.C.™, V.A.C.ULTA™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
381346
Start Date
December 23, 2021
Effective Date
December 23, 2021
Manufacturer
Country
United States of America
Address
12930 IH 10 West, San Antonio, TX, 78249