Device Dossier

Negative-pressure wound therapy system dressing set

Device Dossier for Negative-pressure wound therapy system dressing set (Negative-pressure wound therapy system dressing set, Class IIa, sponsor KCI…

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.

TGA Public Summary