FDA product code OPP
Pump, Infusion, Insulin Bolus
General Hospital·Class 2·21 CFR 880.5725
US regulatory classifications
- US Product Code (FDA)
- OPPView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 880.5725View CFR Regulation →
- Medical specialty
- General Hospital
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
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About this record
Pump, Infusion, Insulin Bolus is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.