Nitric Oxide Generator And Delivery System
The Nitric Oxide Generator and Delivery System is a device that generates and delivers nitric oxide (NO) gas at the point of care for use in conjunction with ventilatory support to treat hypoxic respiratory failure associated with pulmonary hypertension in term and near-term neonates (greater than 34 weeks gestation). The system includes an integrated backup NO delivery system and gas analyzers with alarms for monitoring of delivered NO, nitrogen dioxide, and oxygen levels. Classified as FDA Class 3 requiring Premarket Approval (PMA) and reviewed under Anesthesiology, it is flagged as life-sustaining given its critical role in neonatal respiratory therapy. No regulation number is assigned.
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Basic Information
- Product Code
- QTB
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- AN
- Submission Type
- 2
Device Characteristics
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).
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.