Device Dossier
Negative-pressure wound therapy system foam dressing
Device Dossier for Negative-pressure wound therapy system foam dressing (Negative-pressure wound therapy system foam dressing, Class IIb, sponsor KCI…
- GMDN category: Negative-pressure wound therapy system foam dressing
- Sponsor: KCI Medical
Intended purpose
The V.A.C. Peel and Place Dressing Kit is intended to be applied in an acute, extended, or home care setting where product application is conducted by or under the supervision of a qualified healthcare professional. When used on open wounds, the V.A.C. Peel and Place Dressing Kit with the 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 are: acute and subacute dehisced wounds, traumatic wounds, partial-thickness burns, flaps, grafts and chronic diabetic ulcers, pressure ulcers and venous insufficiency ulcers.