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The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or alternative sites (palm, forearm, upper arm, calf, and thigh). The system is intended to be used by a single patient and should not be shared. The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 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 system is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should only be done during steady state times when blood glucose is not changing rapidly. The IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112 are for use with the IDEAL LIFE GlucoManager™ to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips, palm, forearm, upper arm, calf, and thigh. The IDEAL LIFE Control Solution, Model GCS-0104 is intended for use with IDEAL LIFE GlucoManager™ and IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112. The control solution can be used to check that the qlucose meter and test strips are working properly and that the measurement is accurate. The IDEAL LIFE GlucoManager™ can wirelessly communicate with a communication gateway such as the IDEAL LIFE Pod™ or the IDEAL LIFE Gateway Application™. The IDEAL LIFE Gateway Application receives data wirelessly from IDEAL LIFE devices to transmit over the Internet from the user's mobile device. The Gateway Application is intended to aid people at home and health care professionals to review and evaluate historical blood glucose results, to support effective health care management. The IDEAL LIFE Gateway Application™ makes no interpretation, evaluation, medical iudgment or recommendations for treatment. This device is not intended as a substitute for medical care.

The IDEAL LIFE Gluco-Manager™ Blood Glucose Monitoring System, Model GMM0002 consists of a blood glucose meter, single use test strips and control solution. The new device IDEAL LIFE Gluco-Manager™, Model GMM0002 is based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device. The IDEAL LIFE Gluco-Manager™ can be used alone to measure your blood glucose. If the user would like to transmit blood glucose information for display on a personal computer, the IDEAL LIFE Gluco-Manager™ can wirelessly communicate with a communication gateway (the optional IDEAL LIFE Pod™) or by using the Gateway Application, a mobile medical application.

The IDEAL LIFE Pod™ receives data wirelessly from IDEAL LIFE devices to transmit over the Internet or common telephone lines from the user's home. The Pod is an optional accessory to IDEAL LIFE devices, including the GlucoManager™, the BP-Manager™ and/or the Body Manager™. The Pod is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management. The IDEAL LIFE Pod makes no interpretation, evaluation, medical judgment or recommendations for treatment. This device is not intended as a substitute for medical care.

The IDEAL LIFE Pod is a simple, user-friendly wireless modem accessory that wirelessly receives data from IDEAL LIFE devices and transmits the data to the IDEAL LIFE website. The IDEAL LIFE database is updated securely with the user's information, which is available for review via secure Internet access. Using the Pod, an individual can more easily view and track their blood pressure, blood glucose, and/or body weight information.

The IDEAL LIFE BP-MANAGER™ is a non-invasive blood pressure monitor intended for the measurement of systolic and diastolic blood pressure and heart rate (pulse rate) using the oscillometric technique. The IDEAL LIFE BP-MANAGER™ should be used in adults (individuals aged 18 and older) in a non-clinical environment such as in the home. The IDEAL LIFE BPMANAGER ™ should not be used on infants or children. The end user of this device should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. This device makes no interpretation, evaluation, medical judgeners or recommendations for treatment. Clinical judgment and experience are required for interpretation of information. This device is not intended as a substitute for reedical care. The IDEAL LIFE POD™ is an optional accessory to the IDEAL LIFE BPMANAGER TM and is a transmitter that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting. The IDEAL LIFE POD™ is an optional accessory designed to ssist in the management of user information. This device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check or interpret information transmitted. This device is not intepded as a substitute for medical care.

The IDEAL LIFE BP-MANAGER™ is a single unit software-controlled device with a blood pressure cuff, and operation is automatic. The IDEAL LIFE BP-MANAGFER™ can bc used alone without any other accessories. Blood pressure and heart rate results are displayed on the screen of the IDEAL LIFE BP-MANAGER™. Up to 70 blood pressure readings are stored in the blood pressure computer processor. The device is not intended for self-diagnosis of discase and it is expected that individuals using the IDEAL LIFE BP-MANAGER™ will consult with a physician for interpretation of results. If an individual desires automated graphical presentation of their blood pressure and heart rate data, the IDEAL LIFE POD™ may be purchased separately and used with the IDEAL LIFE BP-MANAGER™ as an optional accessory. The IDEAL LIFE POD™ is not required for operation of the IDEAL LIFE BP-MANAGER™ . The IDEAL LIFE POD™ is a simple transmitter (i.e., a wireless router) that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting.