The System is intended for use by patients, their caregivers, and health
care professionals at home and in health care facilities.
The indication for children (age 4 - 12) 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.
FreeStyle Libre 3 Plus Sensor users:
The FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
(“Reader”) when used with a FreeStyle Libre 3 Plus Continuous Glucose
Monitoring System Sensor (“Sensor”) is indicated for measuring
interstitial uid glucose levels in people (age 2 and older) with diabetes
mellitus, including pregnant women. The Reader and Sensor (“System”)
are designed to replace blood glucose testing in the management of
diabetes, including dosing of insulin.
The System is intended for use by patients, their caregivers, and health
care professionals at home and in health care facilities.
The indication for children (age 2 - 12) 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.
4
To Next Page
Loading...
