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Venturi™ Gauze Wound Care Sets with Portal Drain are intended to be used with the Talley Group range of negative pressure wound therapy pumps. The Talley Group NPWT pumps are indicated use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment. NPWT is contraindicated for patients with: 1. Malignancy in the wound 2. Untreated osteomyelitis 3. Non-enteric and unexplored fistulas 4. Wounds with difficult haemostasis 5. Necrotic tissue with eschar present 6. Exposed vasculature, bone, nerves, or organs.

With the exception of the Portal Drain, there are no changes to the components in the currently marketed gauze dressing kits cleared in 510(K) K080897. The wound care sets connect to Negative Pressure Wound Therapy (NPWT) suction pumps to carry exudate from the wound. The Venturi™ Gauze Wound Care Sets with Portal Drain consist of the following components: Venturi™ Gauze Wound Care Set: Kerlix Antimicrobial gauze wound filler, adhesive film dressing, Portal Drain Assembly; 20ml saline solution and comes with measuring tape and instructions for use. These are supplied as sterile and single use. The Venturi™ MINO Gauze Wound Care sets are have identical contents with the addition of a canister that attaches to the Venturi™ MINO NPWT device to contain the exudate. The Portal Drain assembly is consist of the portal drain which is adhered to a window dressing and is connected to the drain tube which connects at the other end to the NPWT pump via the canister connector assembly. There is a 90° drain tube guide and pinch clamp at the pump end of the assembly for additional safety. The window dressing end of the Portal Drain Assembly is self-adhesive and a small hole is cut in the adhesive film dressing directly over the gauze and the Portal Drain Assembly is placed over the adhesive window dressing ensuring the portal drain is lined up with the hole. The other end of the tubing attaches to the pump to carry exudate from the wound.

The Talley Venturi™ MiNO TG600/14 is intended for use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure wound therapy to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment.

Negative Pressure Wound Therapy (NPWT) is a wound care therapy that uses suction via an electrical pump and a wound dressing. Vacuum Pump Unit: Venturi MiNO NPWT TG600/14 Construction: Flame Retardant ABS Dimensions / Weight: 105mm x 52mm x 112mm / 290g Pressure Range: 80mmHg and 120mmHg