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 IIb, sponsor KCI…

Intended purpose

The V.A.C. Dressing with the brand name, V.A.C. DERMATAC DRAPE and V.A.C. GRANUFOAM Dressing, is a wound dressing which is a component of the V.A.C. Negative Pressure Wound Therapy (NPWT) System. The intended use of the V.A.C. Therapy System is listed below: ACTIV.A.C.™, INFOV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings. • V.A.C.ULTA™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which 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. 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.

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