LungFit PH Verification Kit

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 categoryNitric Oxide Generator And Delivery System

Device IDB882900150

AvailabilityPrescription

Single useYes

MRI safetyMR Unsafe

Phone1-855-586-4359

Emailxxx@xx.xxx