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The NewEra REVA Kit is intended to be used with the NewEra pumps. The 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 formations and by removing exudate and infectious material. NPWT is appropriate for use on the following wounds: - · Pressure Ulcers - · Diabetic/neuropathic ulcers - · Venous insufficiency ulcers - · Chronic, Acute, Traumatic, and Subacute wounds - · Post-operative and dehisced surgical wounds - · Skin flaps and grafts

The NewEra REVA Kit is a convenience kit offered in three sizes: small, medium, and large. The kit contains individually sterilized and packaged products. All products in the kit are 510(k) approved or exempt, except for the IHT NPWT REVA (REVA). The kit includes a REVA to connect to a waste canister, PhaseOne Skin and Wound Cleanser, SkinTac, a ruler, one or more Cutimed Sorbact Compresses, and one or more transparent film IHT drapes (IHT drape), depending on the size, PhaseOne (K131542, K113820, K081009, K071056) and Cutimed Sorbact (K063059) are 510(k) approved devices. The IHT drape (NAD), SkinTac (KOX) and ruler (FTY) are Class I 510(k) exempt. The PhaseOne is used to cleanse the wound. SkinTac is used on the 2" surrounding surface area of the wound (peri-wound). The wound is measured, and the REVA drain is cut to a length apropriate for the wound. The REVA drain is wrapped in Cutimed Sorbact, and Cutimed Sorbact is fluffed and filled appropriately into the wound. The REVA skirt is used to cover over and seal the wound. An IHT Drape is provided for additional material if necessary. The NewEra REVA Kit attaches to an exudate canister to carry exudate from the wound. The NewEra REVA Kit interacts with a NPWT pump that applies a negative pressure to the wound via the components of the kit. The REVA drain and anchor are made of silicone, and the skirt is a clear polyurethane film, which are all common materials currently found in similar wound care products with established biocompatibility.

The NewEra Dome Kit is intended to be used with the NewEra I and II pumps. The 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 formations and by removing exudate and infectious material. NPWT is appropriate for use on the following wounds: Pressure Ulcers, Diabetic/neuropathic ulcers, Venous insufficiency ulcers, Chronic, Acute, Traumatic, and Subacute wounds, Post-operative and dehisced surgical wounds, Explored fistulas, Skin flaps and grafts.

The NewEra Dome Kit is a convenience kit offered in three sizes: small, medium, and large. The kit contains individually sterilized and packaged products, except PhaseOne which is not sterile. All products in the kit are 510(k) approved or exempt, except for the IHT NPWT dome (IHT dome). The kit includes an IHT dome to connect to a waste canister, PhaseOne Skin and Wound Cleanser, SkinTac, a ruler, one or more Cutimed Sorbact Compresses, and one or more transparent film IHT drapes (IHT drape), depending on the size. PhaseOne (K131542, K113820, K071056) and Cutimed Sorbact (K063059) are 510(k) approved devices. The IHT drape, SkinTac and ruler are Class I 510(k) exempt. The PhaseOne is used to cleanse the wound. Cutimed Sorbact is then fluffed and filled into the wound. SkinTac is used on the border of the wound. The IHT Drape is applied to seal the wound. A hole is cut in the drape and the IHT NPWT dome is placed over the hole to allow suction. The NewEra Dome Kit attaches to an exudate canister to carry exudate from the wound and encourage wound closure. The IHT dome and tubing are made of a medical grade thermoplastic elastomer, and the drapes and dome skirt are clear polyurethane films which are all common materials currently found in similar wound care products with established biocompatibility.