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The Exsudex™ Wound Drainage Device is indicated for patients who would benefit from the application of negative pressure to the area of a wound to promote wound healing by drainage of fluids and infected materials from the wound and wound bed. The Exsudex™ Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue (including bone), gases, bodily fluids or infectious materials either during surgery or at the patient's bedside particularly as the device may promote wound healing.

The Exsudex™ unit is a compact portable suction device that can be powered by either an internal battery pack or wall current and is compatible with U.S. electrical standards. The pump will be used in combination with accessory kits to create localized topical negative pressure and promote wound healing by drainage of fluids and infected materials from the wound and wound bed into a disposable canister. The Exsudex™ consists of a medium sized housing that contains a vacuum pump and control system with a location for a fluid canister system. There is also a bacterial filter which is plugged directly into a housing in the pump and replaced as necessary. Accessories include a bed clamp, infusion pole clamp and carry bag. For the expanded indication of use for wound healing the unit is used in conjunction with accessory kits conforming to the guidelines for dressings developed by Chariker et al already available in the U.S. market. This kit consists of individually reviewed medical components that have added instructions for use. The kits are considered "Convenience Kits", falling under the General Surgical classification (see 21 CFR 878.4800.) To use the pump, the suction tube must be connected to the canister and to the drain. After checking the set up and confirming connection between the drain, the Exsudex™ is activated by pressing the start/stop button. To ensure the maintenance of the desired level pressure, Exsudex™ monitors and controls: - . The buildup of pressure - . pressure loss - . pressure tolerance The Exsudex™ is intended for acute, institutional, and long-term care use and only when prescribed by a physician. Product may be indicated for patient home-care, when carefully monitored by licensed home health-care providers, and only when prescribed by a physician.