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The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option. · 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. · The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing. The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts. The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option. · 3M™ V.A.C.® Therapy in the absence of instillation 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. · The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing. The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehised wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Both dressing kits are intended to be used with the 3M™ V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of 3M™ Veraflo™ Therapy that provides Negative Pressure Wound Therapy coupled with controlled delivery and drainage of topical wound treatment solutions and suspensions over the wound bed. The dressing kits provide sterile disposable components needed for delivery of 3MTM VerafloTM Therapy. Each kit contains a wound dressing with 10 mm diameter holes specifically designed for use with 3M™ Veraflo™ Therapy (either the 3M™ V.A.C. Veraflo™ Cleanse Choice™ or the 3MTM Veraflo™ Cleanse Choice Complete™ Dressing), an occlusive drape covering the dressing (either the 3MTM V.A.C. Advanced Drape or the V.A.C. Dermatac™ Drape), a tubing set for connecting the dressing to the negative pressure and instillation pumps (either the 3M™ V.A.C. VeraT.R.A.C.TM Pad or the 3M™ VeraT.R.A.C. Duo™ Tube Set, depending on dressing size) and a wound measuring ruler. The subject dressings differ only in the number of dressing pieces provided in the kit, in the drape materials of construction and in the method of sterilization: - . The 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing Kit is gray in color, has three dressing layers (one with holes, one thin cover layer and one thick cover layer without holes), has a drape constructed of a polyurethane film with acrylic adhesive and is sterilized by irradiation. - The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is blue in color, has only one ● dressing piece (which consists of a combination of the layer with holes and the thin cover layer without holes in the 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing), has a drape constructed of a polyurethane film with acrylic adhesive and a perforated silicone layer, and is sterilized by ethylene oxide (ETO).

The Prevena™ Restor™ Adapti-Form™ Dressing is part of the Prevena™ Restor™ Incision Management System and 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 exudate via the application of negative pressure wound therapy.

The Prevena Restor™ Incision Management System consist of the following components for use together as a system: - Prevena Plus Therapy Unit & canister - Prevena Restor Adapti-Form Dressing: - Foam Dressing with a skin interface layer - V.A.C. Drape - SensaT.R.A.C. Pad - Hydrocolloid Sealing strips The Prevena™ Restor™ Adapti-Form™ Dressing is designed to be compatible for use with previously cleared V.A.C. Negative Pressure Wound Therapy (NPWT) Units: - ActiV.A.C. Therapy Unit, - V.A.C. ULTA Therapy Unit, and - V.A.C. Rx4 Therapy Unit.

Promogran Prisma™, when used without ActiV.A.C.™ Negative Pressure Wound Therapy, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ may be used for the management of: - Diabetic ulcers - Venous ulcers - Pressure ulcers - Ulcers caused by mixed vascular etiologies - Full-thickness & partial thickness wounds - Donor sites and other bleeding surface wounds - Abrasions - Traumatic wounds healing by secondary intention - Dehisced surgical wounds. Promogran Prisma™ when used with ActiV.A.C.TM Negative Pressure Wound Therapy is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy may be used only for the management of: - Diabetic ulcers - Venous ulcers - Pressure ulcers - Partial-thickness burns - Traumatic wounds healing by secondary intention - Dehisced surgical wounds. Compression therapy may only be used with Promogran Prisma™ under professional healthcare supervision. Compression therapy may not be used when Promogran Prisma™ is used with ActiV.A.C.TM Negative Pressure Wound Therapy.

3MTM Promogran Prisma™ is comprised of a sterile, freeze-dried composite of 44% oxidized regenerated cellulose (ORC), 55% collagen and 1 % silver ORC. Silver ORC contains 25% w/w ionically bound silver. It is a primary dressing that can be cut with scissors to fit the wound and used in combination with either a semiocclusive or non-occlusive secondary dressing. The dressing is hexagonal in shape, provided in two sizes (28 cm² and 123 cm²) that are packaged in a hexagonal thermoformed tray and sterilized by gamma irradiation. As described in the product labeling, when used with the ActiV.A.C.TM Negative Pressure Wound Therapy System, seven slits are cut into the 3M™ Promogran Prisma™ by the health care provider before applying the dressing and the components of the ActiV.A.C.™ Negative Pressure Wound Therapy System.

The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option. - 3M™ V.A.C.® Therapy in the absence of instillation 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. - The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

The Veraflo™ Cleanse Choice Complete Dressing Kit is intended to be used with the separately provided V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of Veraflo Therapy that provides V.A.C.® Therapy Negative Pressure Wound Therapy with an instillation option. The system kit provides sterile disposable components needed for delivery of Veraflo Therapy. The kit contains the wound dressing (Veraflo Cleanse Choice Complete Dressing), drape (V.A.C. Dermatac Drape), tubing set (3M™ V.A.C. VeraT.R.A.C.™ Pad or 3M™ V.A.C. VeraT.R.A.C. Duo™ Tube Set) and a wound measuring ruler. The kit components are intended to simplify wound dressing applications by replacing the multiple grey foam dressing pieces in the predicate kit with a single blue foam piece and to provide the V.A.C. Dermatac Drape in the same package with the dressing. Because V.A.C. Dermatac Drape can only be sterilized by ethylene oxide, the kit must also be sterilized by this method.

The V.A.C.® Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy (V.A.C.® Therapy) with an instillation option ( Veraflo™ Therapy). · V.A.C.® Therapy in the absence of instillation 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. · Veraflo™ Therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The V.A.C.® Ulta Negative Pressure Wound Therapy System with and without is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts. · V.A.C.® Therapy in the absence of instillation may also be used for: o The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater. o The management of the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

The V.A.C. 8 Ulta Negative Pressure Wound Therapy System is a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions. The unit is comprised of a vacuum pump and an instillation pump. The vacuum pump delivers negative therapy for the removal of wound exudate and instilled solutions when applied. The instillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps are software controlled. Instillations and negative pressure are delivered through tubing to foam dressings in the wound covered by an occlusive drape. Software monitors both negative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed. Software also provides controls for setting therapy parameters as well as help and alarm functions.

The Dermatac™ Drape and V.A.C. Granufoam™ Dressing are accessories to the: • ACTIV.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™, INFOV.A.C.™, 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.

The Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit is a component of the V.A.C.® Negative Pressure Wound Therapy (NPWT) Systems. The V.A.C. NPWT System is comprised of: - Powered Negative Pressure Wound Therapy (NPWT) Unit ● - A disposable canister which collects wound exudate - A wound interface dressing . - Semi-occlusive wound drape - o Sensing pad and lumen The Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit provides sterile disposable components needed for delivery of negative pressure wound therapy. Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit includes: - (1) V.A.C.® Granufoam™ Dressings (small, medium, or large) ● - (1 or 2) V.A.C. Dermatac TM Drapes - (1) SensaT.R.A.C.™ Pad ● - (1) Ruler