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The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GE200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE200 Blood Glucose Monitoring System should not be used for the diagnosis of , or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by diabetic individuals at home as an aid to monitor the effectiveness of diabetes control. Only limited audible information is available, not intended as an aid for the visually impaired. The GE300 Talking Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GE300 Talking Blood Glucose Test Strips are for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Series Control Solution are for use with the GE300 Talking Blood Glucose Meter and the GE300 Talking Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Monitoring System GM650 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by diabetic individuals at home as an aid to monitor the effectiveness of diabetes control. Only limited and ble, is available, not intended as an aid for the visually impaired. The Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Control Solutions GC650 are for use with the Rightest Blood Glucose Meter GM650 and the Rightest Blood Glucose Test Strip GS650 to check that the meter and test strips are working together properly and that the test is performing correctly. The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Monitoring System GM700 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE200 Blood Glucose Monitoring System consists of the GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, and GE200 Control Solution. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the GE200 Control Solution. The GE300 Talking Blood Glucose Monitoring System consists of the GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, and GE300 Series Control Solution. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the GE300 Series Control Solution. The Rightest Blood Glucose Monitoring System GM650 consists of the Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650, and Rightest Control Solution GC650. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the Rightest Control Solution GC650. The Rightest Blood Glucose Monitoring System GM700 consists of the Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, and Rightest Control Solution GC700. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the Rightest Control Solution GC700.

The GE Blood Glucose Monitoring System 333 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 333 is intended to be used by a single person and should not be shared. The GE Blood Glucose Monitoring System 333 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE Blood Glucose Monitoring System 333 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GE Blood Glucose Test Strips 33 are for use with the GE Blood Glucose Meter 333 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE Blood Glucose Monitoring System 333 consists of the following devices: GE Blood Glucose Meter 333, GE Blood Glucose Test Strip 333, and Rightest Control Solution GC550. The GE333 Blood Glucose Meter and GE Blood Glucose Test Strips 333 are manufactured by BIONIME Corporation. The GE Blood Glucose Meter 333, when used with the GE Blood Glucose Test Strips 333, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 333 is verified by the Rightest Control Solution GC550. The Rightest Control Solution GC550 has been previously been cleared (k092052) and is being repackage for use with the GE Blood Glucose Monitoring System 333. GE Blood Glucose Test Strip 333 paired with GE Blood Glucose Meter 333 that utilizes electrical characteristic technology for measuring the glucose level in human blood. A relatively small drop of blood (minimum requirement of only 0.75 µL) is placed on the disposable GE Test Strip 333 coated with Glucose Oxidase which interacts with the GE Blood Glucose Meter 333. Within 5 seconds after testing, the blood glucose level is indicated on the meter's digital display screen.

The Bionime Rightest Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters: Rightest Blood Glucose Monitoring System GM550 and GM250 with Rightest PC Link Adaptor (GP550), Rightest Blood Glucose Monitoring System GM700 with Rightest PC Link Adaptor (GP550) or Rightest Bluetooth PC Link (GP700), Rightest Blood Glucose Monitoring System GM650 with Rightest PC Link Adaptor for GM650 (GP650), and Rightest Blood Glucose Monitoring System GM300 with Rightest PC Link Adaptor for GM300 (GP300) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. The Bionime Rightest Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional. The GE Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters: GE100 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP550), GE300 Talking Blood Glucose Monitoring System with GE PC Link Adaptor for GE300 (GE GP300) or GE200 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP5500 and GE Bluetooth PC Link (GE GP700) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. The GE Diabetes Management System is not intended to provide treatment decisions. nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed health care professional. The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM300 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System GM300. This device is not intended for testing neonate blood samples. Special conditions for use statement(s): Rightest System provides plasma equivalent results. The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GE200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE200 Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE300 Talking Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GE300 Blood Glucose Test Strip is for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Rightest Blood Glucose Monitoring System GM700 consists of following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700. Rightest Blood Glucose Monitoring System GM650 consists of following devices: Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650. Rightest Control Solution GC650, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM650 is verified by the Rightest Control Solution GC650. Rightest Blood Glucose Monitoring System GM300 consists of following devices: Rightest Blood Glucose Meter GM300, Rightest Blood Glucose Test Strip GS300, Rightest Control Solution GC300, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM300, when used with the Rightest Blood Glucose Test Strips GS300, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM300 is verified by the Rightest Control Solution GC300. GE200 Blood Glucose Monitoring System consists of following devices: GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, GE200 Control Solution, lancing device and steriled lancets. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE200 Blood Glucose Monitoring System is verified by the GE200 Control Solution GE300 Talking Blood Glucose Monitoring System consists of following devices: GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, GE300 Series Control Solution, lancing device and sterile lancets. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE300 Talking Blood Glucose Monitoring System is verified by the GE300 Series Control Solution. The Bionime Rightest Diabetes Management System allows the transfer of blood glucose readings from a compatible Rightest Glucose meter to a PC via PC link adapter (through USB and wireless connection). The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal time periods. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots. The revised system includes: 1) Installation CD with setup files for Rightest GP200 Diabetes Management Software and Rightest PC Link Adapter Driver, 2) One or multiple Rightest Adapters: GP550, GP700, GP650 and GP300 Compatible Meters include: GM250, GM550, GM700, GM650 and GM300. The GE Diabetes Management System allows the transfer of blood glucose readings from a compatible GE Glucose meter to a PC via PC link adapter (through USB and wireless connection). The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal time periods. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots. The revised system includes: 1) Installation CD with setup files for GE GP200 Diabetes Management Software and GE PC Link Adapter Driver, 2) One or multiple GE Adapters: GE GP550, GE GP700 and GE GP300. Compatible Meters include: GE100, GE200 and GE300.