13f5491e-14b2-4839-96c2-aa75830cf09cUpdatePublished32018-07-062015-10-24In Commercial Distribution17540195035130PackageGS10754019503513310In Commercial DistributionCarton07540195035133PrimaryGS1o_two CPAP01CV022801CV0228-CS206449154O-Two Medical Technologies Inc1The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients. The adjustment of the CPAP level is achieved by adjusting the output flow from oxygen therapy regulator or wall outlet. The setting selections noted on the device provide an accurate constant airway pressure at each flow setting.falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-800-387-3405cs@otwo.comK11254600057813CPAP/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 PressureWeightStorage Environment Temperaturefalsefalse