4ec84daa-e1fb-4dbe-8fbf-76dec4056c01NewPublished12021-10-082021-09-30In Commercial Distribution00810071631948PrimaryGS1Curaplex670236-KIT670236-KIT070556204BOUND TREE MEDICAL, LLC1CPAP/Capno Kit O2 Max 3-Set with Chemetron Connector, Adult Medium Mask, Guard FiltertruetruefalsetruefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse63171CPAP/BPAP unit ambient air filter, single-useA non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a single-use device.falseActive37591CPAP/BPAP nasal mask, single-useA non-sterile, 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 single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.falseActiveBYEAttachment, breathing, positive end expiratory pressurefalsefalse