ac102391-5c93-4817-b434-19071d2ab990UpdatePublished42021-02-012016-09-23In Commercial Distribution00606959011908PrimaryGS1PerforMaxPerformax Mask with SE and 4 Point Headgear, MPU, INTL Small1052568080728314Respironics, Inc.1Performax Mask with Standard Elbow and 4 Point Headgear, Multi Patient Use, International, Small falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(724)744-2500respironics.service@philips.comK09264800057814CPAP/BPAP face mask, reusableA flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.falseActiveCBKVENTILATOR, CONTINUOUS, FACILITY USEStorage Environment TemperatureStorage Environment HumidityStorage Environment Temperaturefalsefalse