Negative-pressure wound therapy system foam dressing

Risk Class

Class IIb

Product Type

Procedure Pack

ARTG Category

General

ARTG ID

454285

Start Date

July 03, 2024

Effective Date

July 03, 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

When used on open wounds, the 3M™ V.A.C. Whitefoam™ Dressing Kit with the 3M™ V.A.C.® 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 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, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. The 3M™ V.A.C. Whitefoam™ Dressing Kit is compatible with the following therapy systems: • 3M™ V.A.C.® Ulta Negative Pressure Wound Therapy System • 3M™ V.A.C.® Rx4 Negative Pressure Wound Therapy System • 3M™ ActiV.A.C.™ Negative Pressure Wound Therapy System • 3M™ V.A.C.® Simplicity Negative Pressure Wound Therapy System • 3M™ Prevena™ Plus Negative Pressure Wound Therapy System The 3M™ V.A.C.® Ulta and 3M™ V.A.C.® Rx4 Therapy Systems are integrated negative pressure 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. The 3M™ ActiV.A.C.™, 3M™ V.A.C.® Simplicity and 3M™ Prevena™ Plus Negative Pressure Wound Therapy Systems are integrated negative pressure wound management systems for use in acute, extended and home care settings.