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OneTouch® Reveal™ is indicated for use by individuals or health care professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.

OneTouch® Reveal™ is a Web-based Diabetes management system. The application is designed to assist health care professionals and people with diabetes to track blood glucose levels and insulin doses. The application identifies patterns to help patients manage glycemic control. OneTouch® Reveal™ includes pattern recognition messages, reports, and the ability to view patient data remotely.

The OneTouch® Reveal Diabetes Management Application is a software accessory to the OneTouch® Verio Sync Blood Glucose Monitoring System, and is 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 OneTouch® Reveal Diabetes Management Application receives (from both manual entry and wireless transmission), stores, and sends patient data for display and reporting. The OneTouch® Reveal Diabetes Management Application also communicates with web-based applications. The OneTouch® Reveal Diabetes Management Application is available for use on commercially-available mobile devices and uses generally-available networks and communication protocols.

The OneTouch® Reveal Diabetes Management Application (App) is a diabetes management tool that can help you determine what your blood glucose test results mean. This allows you and your health care professional to better monitor and adjust your diabetes care plan. The App is designed to work in conjunction with the OneTouch® Verio™ Sync Meter. Using the Bluetooth® feature on your meter and Apple® device, blood sugar test results can be sent directly from your meter to the App. Once a blood sugar result is sent to the App you can: Tag the blood sugar result with a meal flag, Receive Low and High Pattern messages, Add carbs, activity, medication data and Notes about your activities, Manually enter other blood sugar test results, Review results on graphs, Share your blood sugar results with others for review and follow-up, and Set reminders to prompt you to complete certain tasks.

The OneTouch® Verio" 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 OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch® Verio" 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 OneTouch® Verio™ Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidlv). The OneTouch® Verio™ Test Strips are for use with the OneTouch® Verio" Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The OneTouch® Verio" Blood Glucose Monitoring System consists of the OneTouch® Verio" Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio" Control Solutions (mid and high levels), the Lancing Device, Sterile Lancets and Clear Cap (sold separately). The OneTouch® Verio" System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.

The Symphony Meter Remote is designed to function both as an in vitro diagnostic device for self-monitoring blood glucose (measure blood glucose concentrations) and as a remote controller of a Symphony Pump for insulin delivery through an infusion set placed subcutaneously. The Symphony Meter Remote is a reusable handheld-battery operated device supplied clean and non-sterile to primarily function as a stand-alone blood glucose meter. With user activation of RF communication between a specific Symphony Meter Remote and specific Symphony Pump, the Symphony Meter Remote also becomes a remote controller of certain features of the Symphony Pump. When paired through radio frequency (RF) communication the Symphony Meter Remote can be used to control bolus insulin delivery, review the status of the Symphony Pump and view and confirm selected pump alerts and warnings. The Symphony Meter Remote incorporates other design features that utilize glucose test data, insulin delivery data, and information important to overall diabetes management, as well as provide interface capability with a personal computer (PC) via data management software.

The OneTouch® Vita™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch Vita™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

The OneTouch® Vita™ Blood Glucose Monitoring System consists of the OneTouch® Vita™ Meter; OneTouch® Vita™ Test Strips (provided separately); OneTouch® Vita™ Control Solution and OneTouch® Vita™ High Control Solution (provided separately); either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with OneTouch® AST ClearCap; and OneTouch® UltraSoft Sterile Lancets.

The ONE Touch® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan blood glucose monitoring systems with data management capabilities.

The OneTouch® Zoom™ Diabetes Management Program is a web-based application that is designed to retrieve blood glucose data from the Microsoft® HealthVault™ and provide trending and reports in order to assist people with diabetes management. The program also includes a stand-alone software driver, branded as OneTouch® Meter Drivers for use with Microsoft® HealthVault™ that downloads blood glucose data from Lifescan Brand blood glucose meters with data management capabilities to Microsoft® HealthVault™ Connection Center, which subsequently upload the data to the user's online Microsoft® HealthVault™ account. The OneTouch® Zoom™ Diabetes Management Program is a .NET based client/server application that runs on Windows 2003 server and supports Internet Explorer 6.0 and higher on the client side. The OneTouch® Meter Drivers for use with Microsoft® HealthVault™ run on Windows XP Service Pack 2 and Windows Vista platforms.

The OneTouch® UltraLink™ Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink™ System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® UltraLink™ Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

The OneTouch® UltraLink Blood Glucose Monitoring System is a modification to the OneTouch® Ultra® 2 Blood Glucose Monitoring System, retaining the features, functions, and user interface of the OneTouch® Ultra® 2 meter while introducing a feature allowing Radio-Frequency transmission of blood glucose results to compatible Medtronic MiniMed, Inc. devices. The OneTouch® UltraLink™ Blood Glucose Monitoring System is composed of the OneTouch® UltraLink™ Blood Glucose meter, OneTouch® Ultra® Test Strips, OneTouch® Ultra® Control Solution, OneTouch® Lancing device, OneTouch® UltraSoft® Lancets, and meter carrying case. System modifications were made only to the blood glucose meter, carrying case, and instructions for use.

The OneTouch® Select™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Select™ System is intended for self-testing outside the body (in vitro diagnostic use) by pcople with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® Select™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

The OneTouch® Select™ Blood Glucose Monitoring System consists of the OneTouch® Select™ Meter, OneTouch® Select™ Test Strips (provided separately), OneTouch® Select™ Control Solution (provided separately), OneTouch® Select™ High Control Solution (provided separately), either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with Onc Touch® AST ClearCap and OneTouch® UltraSoft Sterile Lancets. The OneTouch® Select™ meter, test strip and high control solution are modifications of the OneTouch Ultra 2® meter, test strip and normal control solution, respectively. There are no changes to other system testing components compared to the currently marketed product.

The OneTouch Ultra Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch Ultra Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

The OneTouch Ultra Blood Glucose Monitoring System consists of the OneTouch Ultra Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch UltraSoft Blood Sampler with OneTouch ClearCap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® meter hardware and software has been modified. There are no changes to other system testing components compared to the currently marketed product.

The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch UltraMini System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch UltraMini Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

The OneTouch UltraMini Blood Glucose Monitoring System consists of the OneTouch UltraMini Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch Lancing Device with AST Clear Cap or OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch UltraMini Meter. The OneTouch Lancing Device with AST Clear Cap is a modification (smaller size) of the existing OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap (class I, exempt device). There are no changes to any of the other system testing components compared to the currently marketed product.