c1794659-beb5-4775-93f9-42588eec26f9NewPublished12020-12-242020-12-16In Commercial Distribution10841470100350PackageGS10084147010035310In Commercial Distribution00841470100353PrimaryGS1O2-MAX313-7538XNF030619483PULMODYNE INC1falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse37498Respiratory oxygen therapy systemAn assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.falseObsoleteBYEAttachment, Breathing, Positive End Expiratory PressureDevice Size Text, specifyAdult Medium MaskDevice Size Text, specify10.0cm Valvefalsefalse