| Device |
nitric oxide generator and delivery system |
| 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). |
| Physical State |
Enclosed nitric oxide generator and gas monitoring system with external connectors and accessories for delivery of nitric oxide and sampling of delivered gas. |
| Technical Method |
The system consists of an electrically powered device with NO generator module containing electrodes used for generation of nitric oxide and sensors for measurement of delivered gas. Generated nitric oxide gas is delivered in conjunction with ventilatory support. |
| Target Area |
Lungs (pulmonary vasculature) |
| Review Panel |
Anesthesiology |
|---|
| Product Code | QTB |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
