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The CONTOUR® NEXT GEN Blood Glucose Monitoring System consists of the CONTOUR® NEXT GEN meter, CONTOUR® NEXT blood glucose test strips and the CONTOUR® Diabetes app. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT GEN 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 in monitoring the effectiveness of a diabetes control program. The CONTOUR® NEXT GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The system is intended for in vitro diagnostic use only. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood qlucose test strips, and the CONTOUR® Diabetes app. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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 in monitoring the effectiveness of a diabetes control program. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips. The system is intended for in vitro diagnostic use only.

CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE Blood Glucose Meters have Bluetooth Low Energy technology built in so that the meters can communicate wirelessly to smart phones and tablets. The CONTOUR® NEXT GEN meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution and CONTOUR® PLUS BLUE meter uses CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution respectively. The meters can be connected to the CONTOUR® Diabetes app. Both the meters use two replaceable coin cell batteries. Both the meters' shape is a traditional oval form factor. The CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE meters have smartLIGHT® and smartCOLOR® indicator features respectively to see if a glucose result is above, within, or below target range.

The Contour® next GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour® next blood glucose test strips and the Contour® Diabetes app. The Contour® next GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® next GEN 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 in monitoring the effectiveness of a diabetes control program. The Contour® next GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The system is intended for in vitro diagnostic use only.

CONTOUR® NEXT GEN Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to smart phones and tablets. The meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution. The meter can be connected to the CONTOUR® Diabetes app. It uses two replaceable CR2032 or DL2032 coin cell batteries. The meter's shape is a traditional oval form factor, and it includes an illuminated strip port with colors indicating if a glucose result is above, within, or below target.

The CONTOUR®NEXT EZ blood glucose monitoring system is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared. The system is intended for self testing outside the body (in vitro diagnostic use) and is to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT EZ blood glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The Contour Next EZ Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next EZ Blood Glucose Monitoring System. The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.

The Contour Next blood glucose monitoring system is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only, and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The Contour Next blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The system consists of a Contour Next blood glucose meter. Contour Next control solutions. Contour Next test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples. The Contour Next blood glucose monitoring system is not intended for the diagnosis or screening for diabetes mellitus and is not intended for use on neonates. The Contour Next Link Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for singlepatient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The Contour Next Link Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). Contour Next Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples. The Contour Next Link Wireless Blood Glucose Monitoring System is intended to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication. The Contour Next Link Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Contour Next Link Wireless Blood Glucose Meter: The Contour Next Link Wireless Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next Link Wireless Blood Glucose Monitoring System. The System also contains radio frequency (RF) functions for sending blood glucose results to compatible Medtronic MiniMed insulin pumps. The RF function can also serve as a pass through for data being transmitted from Medtronic MiniMed insulin pumps to Medtronic's MiniMed PC-based data manaqement software. The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD qlucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed. Contour Next Blood Glucose Meter: The Contour Next Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next Blood Glucose Monitoring System. The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD qlucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.