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
When used on open wounds, the V.A.C.® Granufoam™ Dressing Kit with a Solventum™ Negative Pressure Wound Therapy Unit 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. When used on closed surgical incisions, the V.A.C.® Granufoam™ Dressing Kit with a Solventum™ Negative Pressure Wound Therapy Unit is 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.