FDA product code QCC

Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

Clinical Chemistry·Class 2·21 CFR 862.1358
US regulatory classifications
US Product Code (FDA)
QCC
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.1358
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors.

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About this record

Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals is a medical device type in the Clinical Chemistry 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.