Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Class C medical device
Abbott Diabetes Care Ltd
General Hospital
The FreeStyle Libre Flash Glucose Monitoring System is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus. 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 FreeStyle Libre Flash Glucose Monitoring System and also for interpreting or assisting the child to interpret FreeStyle Libre readings.
Device System Info:[Sterile Medical Device], Sterile Sensor Pack (e-beam irradiation); Models: FreeStyle Libre Flash Glucose Monitoring System (Reader) - 71723-01, FreeStyle Libre Flash Glucose Monitoring System (Sensor) - 71730-01, FreeStyle Libre Glucose Data Management Software - 72033-01
2017-05-02