QTB · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
QTB
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
AN
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
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).