2eecb79d-c459-4134-8a4c-1a0ee0806b56UpdatePublished32018-07-062015-05-05In Commercial DistributionB00287050PrimaryHIBCCRescuer Emergency CPAP System87058705200103823B.L.S. Systems Limited1Rescuer Emergency CPAP System with Medium sized CPAP mask and pre-attached bonnet used for acute episodes of respiratory distress.falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse9053391069tedreesor@blssystemsltd.comK12261000057813CPAP/BPAP face mask, single-useA non-sterile, 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/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 single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.falseActiveBYEAttachment, Breathing, Positive End Expiratory PressureDevice Size Text, specifyMedium CPAP MaskStorage Environment Humidityfalsefalse