Product code NOU
- Device name
- Continuous, Ventilator, Home Use
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5895
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
- Source
- FDA openFDA device classification dataset