QTB

Nitric Oxide Generator And Delivery System

Product code

QTB

Device name

Nitric Oxide Generator And Delivery System

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

Flag

Life-sustaining / life-supporting

FDA classification definition

The system is intended for generation and delivery of nitric oxide (NO) for use in conjunction with ventilatory support and other appropriate agents to produce, at point of care, and deliver nitric oxide (NO) to treat term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with pulmonary hypertension. The system includes an integrated backup NO delivery system and gas analyzers with an alarm for monitoring of delivered NO, nitrogen dioxide (NO2), and oxygen (O2).

Definition text from the FDA device classification database (U.S. federal government work, public domain).