Product code OPP
- Device name
- Pump, Infusion, Insulin Bolus
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5725
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
- Source
- FDA openFDA device classification dataset