3M™ Prevena™ Plus 125 Therapy Unit with 3M™ Prevena™ Plus 150mL Canister - Negative-pressure wound therapy system, battery-powered, single-use
Access comprehensive regulatory information for 3M™ Prevena™ Plus 125 Therapy Unit with 3M™ Prevena™ Plus 150mL Canister - Negative-pressure wound therapy system, battery-powered, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by KCI Medical Australia Pty Ltd, manufactured by KCI USA Inc in United States of America. The device registration started on May 09, 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.
The 3M™ Prevena™ Plus 125 Therapy Unit, when used with the 3M™ Prevena™ Dressings (3M™ Prevena™ Plus Incision management System), is intended to manage the environment of closed surgical incisions and surrounding intact skin in patients at risk for developing post-operative complications, such as infection, by maintaining a closed environment via the application of a negative pressure wound therapy system to the incision. The 3M™ Prevena™ Plus 125 Therapy Unit, when used with compatible 3M™ V.A.C.® Dressings on open wounds (3M™ Prevena™ Plus negative Pressure Wound Therapy System), is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing oedema, 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.