Important Safety Information
Indications for Use
The FreeStyle Libre Flash Glucose Monitoring System Reader (“Reader”)
when used with a FreeStyle Libre System Sensor (“Sensor”) is indicated for
measuring interstitial fluid glucose levels in people (age 4 and older) with
diabetes mellitus . The Reader and Sensor are designed to replace blood
glucose testing in the self-management of diabetes, including dosing of
insulin .
The indication for children (age 4 - 17) is limited to those who are
supervised by a caregiver who is at least 18 years of age . The caregiver is
responsible for managing or assisting the child to manage the Reader and
Sensor and also for interpreting or assisting the child to interpret Sensor
glucose readings .
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