df83be25-7d4e-4222-beb8-221436960f2cUpdatePublished32018-07-062016-09-22In Commercial DistributionB036100657PrimaryHIBCCSleepWeaver Elan - Mask Only - Regular - Leopard100657100657012721295CIRCADIANCE, LLC1SleepWeaver Elan Cloth Nasal PAP Mask Only - Regular - LeopardfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse1-888-825-9640info@circadiance.comK12075700057815CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose 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. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.falseActiveBZDVentilator, Non-Continuous (Respirator)falsefalse