Device typeProfessional high-flow respiratory unit, humidifying, manual: An electrically-powered device designed to deliver high-flow (exceeding peak inspiratory flow) heated and humidified ambient air or air/oxygen, at a manually set oxygen concentration (FiO2), to a spontaneously breathing patient. It is intended for use by a healthcare provider as part of noninvasive ventilation (NIV), in a peri-anaesthesia environment, or for a patient experiencing a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD)]. It typically consists of a gas flow generator, a heating element, and humidification chamber.
FDA categoryHigh Flow/High Velocity Humidified Oxygen Delivery Device
Device ID09420012466662
Catalog numberPT301US
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information