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Nitric Oxide Generator And Delivery System

Page Type
Product Code
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
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code QTB to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.

Nitric Oxide Generator And Delivery System

Page Type
Product Code
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
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code QTB to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.