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AeroNOx 2.0 Nitric Oxide Delivery Device
AeroNOx Test Circuit
Details
Device typeNitric oxide delivery unit, system-based: A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.
FDA categoryApparatus, Nitric Oxide Delivery
Device ID00850018561679
Catalog number738-1889
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information