Nitric Oxide Generator And Delivery System
Basic Information
- Device Name
- Nitric Oxide Generator And Delivery System
- Trade Name
- LungFit PH
- PMA Number
- P200044
- Device Class
- FDA Class 3
- Product Code
- QTB
- Generic Name
- Nitric Oxide Generator and Delivery System
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 28, 2022
- Date Received
- November 17, 2020
- Expedited Review
- N
- Docket Number
- 22M-2064
Advisory Committee Statement
Approval for The LungFit® PH. The device is indicated to deliver nitric oxide (NO), a vasodilator, generated by the device into the inspiratory limb of the patient breathing circuit of a ventilator in a way that provides a constant concentration of NO, as set by the user, to the patient throughout the inspired breath. The LungFit® PH provides continuous integrated monitoring of inspired oxygen (O2), nitrogen dioxide (NO2) and NO, and a comprehensive alarm system. The LungFit® PH includes an integrated backup NO delivery system that is a completely independent backup NO generating system; it has its own NO generator and gas flow delivery system. The backup flow is delivered at 1 L/min at 220ppm NO to either a ventilator circuit or to a bagging system, depending upon the user selected setting. The NO generated by the LungFit® PH System is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QTB | Nitric Oxide Generator And Delivery System | FDA class 3 | Unknown |