QTB — Nitric Oxide Generator And Delivery System Class III
FDA product code QTB covers "Nitric Oxide Generator And Delivery System", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QTB
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- No
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).