GENADYNE BIOTECHNOLOGIES INC. UP-S01 UNO Plus Negative Pressure Wound Therapy Device

The Genadyne UNO+ NPWT (Ref # UP-S01) is a multi-patient use, rechargeable Negative Pressure Wound Therapy unit, designed for moderate to low severity wounds. The UNO+ NPWT features an interface panel which provides 5 alerts to the user, selectable therapy modes (continuous mode and variable mode) and multi pressure options (40mmHg, 60mmHg,80mmHg, 100mmHg or 125mmHg). The UNO+ NPWT is packaged in a box that includes a universal charger, USB cable, a user manual and a user carry bag. It will be made compatible with the dressing kits that was already approved under K143726. The dressing kits includes the transparent film dressings, a choice of wound filler (i.e. XLR8 green foam, Genadyne Hybrid Dressing) and the XLR8 Port Pad. The UNO+ NPWT is designed to be used with a canister collection system. The canister will have 2 sizes available (200cc and 300cc). Therapy duration of the dressing may be less than indicated if clinical practice or other factors such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes.