FreeStyle Libre Flash Glucose Monitoring System Sensor - Subcutaneous glucose sensor

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
01-12-2017

可用日期:

Abbott Australasia Pty Ltd T/A Abbott Diabetes Care

类:

Class III

厂商:

Abbott Diabetes Care Ltd Range Road, Witney, Oxon, OX290YL United Kingdom

治疗领域:

59016 - Subcutaneous glucose sensor

疗效迹象:

The Sensor measures and stores glucose readings when worn on your body. The sensor has a small, flexible tip that is inserted just under the skin and can be worn for up to 14 days when it needs to be replaced. The sensor is a component of the FreeStyle Libre Flash Glucose Monitoring System and is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with insulin dependent 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.

授权状态:

A

授权日期:

2016-02-05

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