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Medisign MM1000 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). The Medisign MM1000 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1000 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use. Medisign MM1100 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). The Medisign MM1100 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1100 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use. Medisign MM1200 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). The Medisign MM1200 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use. Smart Diabetes Bluetooth Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (invitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). The Smart Diabetes Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use. Smart Diabetes Glucose Control Solutions are intended for use with Smart Diabetes Bluetooth meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together. Medisign MM1000 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system. The Medisign MM1000 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1000 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use. Medisign MM1100 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system. The Medisign MM1100 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1100 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use. Medisign MM1200 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system. The Medisign MM1200 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use. Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system. The Smart Diabetes Pro Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Pro Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use. Smart Diabetes Glucose Control Solutions are for use with the Smart Diabetes Bluetooth Pro meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.

Medisign® Blood Glucose Monitoring System measures the glucose in the fresh capillary whole blood sample by using a small electrical current produced by chemical reaction between glucose in the blood and glucose oxidase on the test strip. This current is proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements are reported as plasma equivalents. Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood equivalent test strips. Medisign® MM 1000 BT Blood Glucose Monitoring System, Medisign® MM 1100 BT Blood Glucose Monitoring System, Medisign® MM1200 BT and Smart Diabetes Bluetooth Blood Glucose Monitoring System are basically provided with a blood glucose meter and a carrying bag including user manual, quick reference manual and log book. Blood glucose test strips (10T, 25T, 50T), blood glucose control solutions (Level 1, Level 3), lancing device, lancets, batteries (CR2032), diabetes management software, and data transporting cable are sold separately. Medisign® MM1000 BT MULTI Blood Glucose Monitoring System, Medisign® MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign® MM1200 BT MULTI and Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System are basically provided with a blood glucose meter and a carrying bag including user manual, quick reference manual. Disposable lancing device, blood glucose test strips (10T, 25T, 50T), blood glucose control solutions (Level 1, Level 3), batteries (CR2032) diabetes management software, and data transporting cable are sold separately. Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) -2.5 units, redox mediator - 32.3 µg and buffer & non-reactant - 50.5µg Each box of control solutions (Level 1, Level 2 and Level 3) contains one vial of aqueous control solution (4ml each): Level 1 contains 0.03% concentrations of glucose (approximately 40 mg/dL), Level 2 contains 0.11% concentrations of glucose (approximately 85 mg/dL) and Level 3 contains 0.23% concentrations of glucose (approximately 260 mg/dL). The system contains Bluetooth wireless technology. This device complies with U.S. federal guidelines, Part 15 of the FCC Rules for devices with RF capability. Operation is subject to the following two conditions: - This device may not cause harmful interference. - · This device must accept any interference received, including interference that may cause undesirable operation. The Bluetooth wireless technology is used to transfer meter test results to a mobile APP.

The Medisign® MM3000 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 Medisign® MM3000 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Medisign® MM3000 meter contains some speaking functions but is not intended for use by the visually impaired. The Medisign® MM3000 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 Medisign® MM3000 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 Medisign® MM3000Test Strips are for use with the Medisign® MM3000 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Medisign® Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly. The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective controlling and managing blood glucose. The Medisign® MM3000 Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) fresh capillary whole blood from fingertip, palm, or forearm. The Medisign® Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The Medisign® MM3000 Multi meter contains some speaking functions but is not intended for use by the visually impaired. The Medisign® MM3000 Multi 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 Medisign® MM3000 Multi Blood Glucose Test Strips are for use with the Medisign® MM3000 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Medisign® MM3000 Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly. The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective controlling and managing blood glucose.

Medisign Blood Glucose Monitoring System measures the glucose in the whole blood sample by using a small electrical current produced by chemical reaction between glucose in the blood and glucose oxidase (GOD) on the test strip. This current is proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements are reported as plasma equivalents. Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood referenced test strips. Medisign MM3000 Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, a lancing device, sterile lancets, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Blood glucose test strips, blood glucose control solutions (1, 2, 3 levels), diabetes management software, and data transporting cable are sold separately. Medisign MM3000 Multi Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Disposable lancing device, blood glucose test strips, blood glucose control solutions (1,2,3 levels), diabetes management software, and data transporting cable are sold separately. Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Also, each box may contain 25 test strips packed with single aluminum foiled pack or 50 test strips packed with single aluminum foiled pack. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) -2.5 units, redox mediator - 32.3ug and buffer & non-reactant - 50.5uq. Each box of control solutions (1, 2, 3 levels) contains one vial of aqueous control solution (4ml each): Level 1 contains 0.03% concentrations of glucose (approximately 40 mg/dL) and Level 2 contains 0.11% concentrations of glucose (approximately 85 mg/dL) and Level 3 contains 0.23% concentrations of glucose (approximately 260 mg/dL).

Medisign MM1000 Blood Glucose Monitoring System, MM1100 Blood Glucose Monitoring System, and Medisign MM1200 Blood Glucose Monitoring System are intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for selftesting by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates. The alternative site testing (palm and forearm) in the systems can only be used during steady-state blood glucose conditions. The Medisign™ MM1000 test strip is to be used with Medisign™ MM1000 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1000 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use. The Medisign™ MM1100 test strip is to be used with Medisign™ MM1100 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1100 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use. The Medisign™ MM1200 test strip is to be used with Medisign™ MM1200 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1200 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for selftesting by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use. Medisign MM1000 Multi Blood Glucose Monitoring System, Medisign MM1100 Multi Blood Glucose Monitoring System, and Medisign MM1200 Multi Blood Glucose Monitoring System are intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in clinical settings. It is intended for use outside of the body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates. The alternative site testing (palm and forearm) in the systems can only be used during steady-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system. The Medisign™ MM1000 Multi Blood Glucose Test strip is to be used with Medisign™ MM1000 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1000 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing, The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use. The Medisign™ MM1100 Multi Blood Glucose Test strip is to be used with Medisign™ MM1100 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1100 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing. The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use. The Medisign™ MM1200 Multi Blood Glucose Test strip is to be used with Medisign™ MM1200 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign™ MM1200 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing. The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use. Medisign™ Glucose Control Solutions are for use with Medisign™ Brand Blood Glucose Meters and Medisign™ Test Strips to check that the meter and test strips are working together properly. Medisign™ Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign™ Glucose Control Solutions are for in vitro diagnostic use.

Medisign MM1000 Blood Glucose Monitoring System, MM1100 Blood Glucose Monitoring System, and Medisign MM1200 Blood Glucose Monitoring System are basically provided with a blood glucose meter, blood glucose test strips (10T), and a carrying bag including user manual, quick reference manual and log book. Blood glucose test strips (25T, 50T), blood glucose control solutions (Level A, Level B), check strip, diabetes management software, and data transporting cable are sold separately. Medisign MM1000 Multi Blood Glucose Monitoring System, Medisign MM1100 Multi Blood Glucose Monitoring System, and Medisign MM1200 Multi Blood Glucose Monitoring System are basically provided with a blood glucose meter, blood glucose test strips (107), and a carrying bag including user manual, quick reference manual and log book. Disposable lancing device, blood glucose test strips (25T, 50T), blood glucose control solutions (Level A, Level B), check strip, diabetes management software, and data transporting cable are sold separately. Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) - 2.5 units, redox mediator - 32.3µg and buffer & non-reactant - 50.5µg. Each box of control solutions (Level A and Level B) contains one vial of aqueous control solution (4ml each): Level A contains 0.11% concentrations of glucose (approximately 120 mg/dL) and Level B contains 0.23% concentrations of glucose (approximately 320 mg/dL). Only the difference among six blood glucose monitoring systems above is the appearance of the top cases of the meters. Six blood glucose monitoring systems use the same PCB, the same LCD, the same Software, the same test strip, and the same control solution.