0cc29aa0-a31d-46fd-a110-7be64353d9bcUpdatePublished52021-03-012016-06-102021-02-28Not in Commercial Distribution00606959025073PrimaryGS1AMARAAMARA MASK with RS FRAME AND RS Headgear, Small, Japan1090241080728314Respironics, Inc.1AMARA MASK WITH RS FRAME AND RS HEADGEAR SMALL, JAPANfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(724)744-2500respironics.service@philips.com57814CPAP/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.falseActiveBZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)Storage Environment TemperatureStorage Environment HumidityStorage Environment Temperaturefalsefalse