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The Livongo Blood Glucose Monitoring System (BG1000) is composed of the Livongo Blood Glucose Meter (BG1000) and Livongo Blood Glucose Test Strips (BG1000). The system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The system is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control programs. The Livongo Blood Glucose Monitoring System (BG1000) is intended for single-patient use and should not be shared. The system is for in vitro diagnostic use and is not intended for the diagnosis of or diabetes, nor intended for use on neonates.

The Livongo Blood Glucose Monitoring System (BG1000) is an Over-The-Counter (OTC) system designed for the self-monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. The system consists of the following components: - Livongo Blood Glucose Meter (BG1000) ("Livongo meter") - Livongo Blood Glucose Test Strips (BG1000) ("Livongo test strips") - Livongo Lancing Device - class I accessory - Livongo Lancets - Livongo Level 1 Control Solution - Livongo Level 2 Control Solution - AC Adapter (wall charger) and USB Charger Set - Carrying Case The Livongo meter is a cellular-connected handheld device that monitors glucose in the blood to help with the management and treatment of diabetes. The meter also incorporates additional features to aid in self-monitoring of blood glucose including tables and logs, graphs. The blood glucose levels are displayed on the screen and stored in the meter's memory, and may also be transmitted over a cellular network to a secure server. The Livongo test strips will be packaged in 50 count of strips in sealed vials. The Livongo Control Solutions consist of an aqueous based mixture prepared with a known amount of glucose concentration. It is available in two levels, Level 1 and Level 2.