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The Fingertip Pulse Oximeter (DB12) is used for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult patients in hospitals, physician's office, clinical settings and home care environment. The Fingertip Pulse Oximeter (DB12) is not intended for continuous monitoring.

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DA01 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample (from the finger and the palm,). The alternate site testing can be only used during steady-state blood glucose monitoring. The DA01 Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates. The DA01 Blood Glucose Test Strips are used with the DA01 Glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger and the palm. The DiaLife mini is a PC-based software intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The DiaLife mini software receives via USB, stores, and uses patient data for display and reporting. It is intended for use as an accessory to DELBio DA01 Blood Glucose Monitoring System.

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DiaTrue Plus Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample from the fingertip and the palm. The alternate site testing can be only used during steady-state blood glucose monitoring. The DiaTrue Plus Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates. The DiaTrue Plus Blood Glucose Test Strips are used with the DiaTrue Plus Glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip and the palm. The DiaTrue Glucose Control Solutions are for use with the DiaTrue Plus Blood Glucose Test Strips and the DiaTrue Plus Glucose meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly. The DiaLife Mini Blood Glucose Management Software is designed for use in the home with the DiaTrue Plus Blood Glucose Monitoring System to allow users to transmit data from meter to their computer. It is an optional data management software accessory for use with the DiaTrue Plus Blood Glucose Monitoring System.

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DA01 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample (from the finger and the palm). The alternate site testing can be only used during steady-state blood glucose monitoring. The DA01 Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates. The DA01 Blood Glucose Test Strips are used with the DA01 Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger and the palm. The DA06 Glucose Control Solutions are for use with the DA01 Blood Glucose Test Strips and the DA01 Glucose Meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly.

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The DiaTrue Plus Blood Glucose Monitoring System is an in vitro diagnostic medical device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control and should not be shared. The device should not be used for screening or diagnosis of diabetes or for testing neonates. The DiaTrue Plus Blood Glucose Meter is intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body. It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control. The DiaTrue Plus Blood Glucose Test Strips are intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The Blood Glucose Test Strips must be used with the DiaTrue Plus Blood Glucose Meter. Testing is done outside the body. They are indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control. DiaTrue Glucose Control solution: For use with DiaTrue Blood Glucose Meter and DiaTrue Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Three levels of control solution are provided: Level I, Level II and Level III.

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DiaCheck Smart Blood Glucose Monitoring System: The DiaCheck Smart Blood Glucose Monitoring System is intended for the quantitative rno Blacmost of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DiaCheck Smart Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Smart Blood Glucose Test Strips: The DiaCheck Smart Blood Glucose Test Strips are for use with the DiaCheck Smart Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The Test Strip is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Glucose Control Solution: The DiaCheck Control solutions are intended for use with DiaCheck Blood Glucose The DiaCheck Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly. DiaCheck Superior Blood Glucose Monitoring System: The DiaCheck Superior Blood Glucose Monitoring System is intended for the rne Black our of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DiaCheck Superior Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Superior Blood Glucose Test Strip: The DiaCheck Superior Blood Glucose Test Strips are for use with the DiaCheck rne Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The Test Strip is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Glucose Control Solution: The DiaCheck Control solutions are intended for use with DiaCheck Blood Glucose The DiaCheck Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.

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The Diacheck Premium Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Diacheck Premium Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. The Diacheck Premium Blood Glucose Test Strips are for use with the Diacheck Premium Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The test strip is intended for self testing outside the bod (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. The Diacheck Control solutions are intended for use with Diacheck Premium Blood Glucose Meter and Diacheck Premium Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.

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