Search Results

The Extended Reservoir is indicated for the subcutaneous infusion including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.

Extended Reservoir (herein referred to as "EWR" or "MMT-342") is a sterile medication container designed for single use. The Extended Reservoir (MMT-342) is a component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring subcutaneous administered insulin, to maintain acceptable blood glucose levels. The Extended Reservoir (subject device) is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.

MiniMed Connect is intended to provide a secondary display of continuous glucose monitoring and/or insulin pump data on a suitable consumer electronic device to care partners and users of a MiniMed 530G system or Paradigm REAL-Time Revel system for the purpose of passive monitoring. MiniMed Connect system is not intended to replace the real-time display of continuous glucose monitoring and/or insulin pump data on the primary display device (i.e. the sensor-augmented pump). All therapy decisions should be based on blood glucose measurements obtained from a blood glucose meter. The MiniMed Connect is not intended to analyze or modify the continuous glucose monitor data and/or insulin pump data that it receives. Nor is it intended to control any function of the connecting continuous glucose monitor system and/or insulin pump. The MiniMed Connect is not intended to serve as a replacement for a primary display device for the continuous glucose monitoring system and/or insulin pump data. The MiniMed Connect is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.

MiniMed® Connect is a secondary display of continuous glucose monitor and/or insulin pump data on a suitable consumer electronic device for insulin pump patients and their care partners. This system is designed as an optional accessory to compatible sensor-augmented pump systems. MiniMed® Connect consists of a MiniMed® Connect app (for a local secondary display), the CareLink® Connect module of CareLink® Personal (for a remote secondary display), and the MiniMed® Connect uploader (for data transmission to the local app). The MiniMed® Connect uploader is a small, battery-powered, ambulatory device that is carried with the patient in near proximity to the insulin pump. Its rechargeable battery is charged as needed (approximately once a day) using a USB Charger that accompanies the device. The MiniMed® Connect uploader receives continuous glucose monitor and/or insulin pump data from the sensor-augmented insulin pump using a proprietary 916.5 MHz RF, and then converts it into a 2.4 GHz Bluetooth Low Energy (BLE) format. This BLE formatted data can then be read by the MiniMed® Connect app installed on a compatible consumer electronics device with BLE capabilities. The MiniMed® Connect app reads the BLE data transmission and displays it on the patient's compatible consumer electronic device. The MiniMed® Connect app then uploads the continuous glucose monitor and/or insulin pump data to CareLink® Connect, the remote monitoring module of CareLink® Personal. Authorized care partners can access CareLink® Connect to view the patient's continuous glucose monitor and/or insulin pump data through an Internet-enabled consumer electronic device for the purpose of passive monitoring. Accessories associated with this system include: - USB Charger (for charging the MiniMed® Connect uploader) .

The Medtronic CareLink™ USB Connector is indicated for use by patients at home and clinicians in a medical office setting to facilitate communication between Medtronic diabetes ther apy management devices that use Paradigm-compatible RF telemetry and a personal computer that uses data management application software.

The Medtronic MiniMed CareLink USB Connector is an accessory device that facilitates wireless communication between compatible Medtronic MiniMed radiofrequency telemetry devices and a personal computer. The hardware component of the CareLink USB Connector consists of a radio-frequency (RF) transceiver enclosed in a plastic housing and one USB connector that is compatible with a type A (female) USB port of a personal computer (PC) or a USB hub. The CareLink USB Connector has a form factor similar to a USB flash memory stick and will by recognized by the PC as a USB device. The CareLink USB Connector is designed for use with Medtronic MiniMed devices that use Paradigm radiofrequency telemetry. Data is transferred between Medtronic MiniMed Paradigm RF compatible devices and a personal computer (PC) using select Medtronic MiniMed data management software applications.

The Medtronic MiniMed ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting in programming insulin basal delivery patterns, insulin delivery rates and current basal rates in effect on the pump. It is intended to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-512). The Medtronic MiniMed ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting as a tool to save and adjust Medtronic MiniMed Paradigm pump settings using a personal computer.

The Medtronic MiniMed ParadigmPAL is data transfer software designated by Medtronic MiniMed to interface with hardware models 7304 (ComLink) and HS-3222 (Paradigm Link); personal computer and a Paradigm insulin infusion pump. The ParadigmPAL system is designed for use with Medtronic MiniMed infusion pumps (model 512 and model 712).

The Medtronic MiniMed Paradigm Model 712 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The Paradigm Model 712 is an external, portable insulin pump, designed for continuous delivery of insulin. It is designed to deliver 0.00 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insulin per meal bolus. This pump will include a bolus estimator feature that can be tailored to an individual user's insulin sensitivity, insulin to carbohydrate ratio, and target BG (Blood Glucose). Also, there is a BG reminder feature, allowing the user to set daily and post-bolus reminders to check BG readings. The insulin programming step size will allow users to program insulin delivery in steps of 0.1 units for boluses and 0.05 units for basal delivery. The Model 712 accommodates a proprietary 3.0 ml reservoir. This new reservoir mates with the existing and future Paradigm infusion sets.

Model 512 Insulin Pump: The Medtronic MiniMed Paradigm Model 512 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. BD Paradigm Link Glucose Monitor: The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellius in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The BD Paradigm Link Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertin. Model 512 Insulin Pump and BD Paradigm Link Glucose Monitor: When used together, the BD Paradigm Link Glucose Monitor can automatically telemeter glucose values to the Model 512 Insulin Pump using radio frequency communication, The glucose value received by the Model 512 Insulin Pump is used as the default glucose value by the pump's Bolus Wizard feature if the Bolus Wizard is used within 12 minutes of the glucose value transmission. The BD Link Glucose Monitor can also serve as a radio frequency interface to allow communication between the Model 512 Insulin Pump and a personal computer running the appropriate Medtronic MiniMed communications software.

The Paradigm Model 512 external insulin pump is an ambulatory, battery operated, rateprogrammable microinfusion pump, designed for continuous delivery of insulin. A reservoir is driven by a drive motor to deliver preset basal profiles and patient programmed bolus amounts of insulin through infusion sets into subcutaneous tissue. This pump incorporates new software improvements over the predicate model and is designed to allow installation of upgraded software with new features through radio frequency telemetry without the need to replace any pump components. The BD Paradigm Link Blood Glucose Monitor is an in-vitro diagnostic device for use in the quantitative measurement of glucose in capillary blood collected from fingertips. The BD Paradigm Link™ is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 seconds while requiring a very small (0.3 µL) sample. When the BD Paradigm Link Glucose Monitor is used together with the Medtronic MiniMed 512 External Insulin Pump, blood glucose test values obtained using the BD Paradigm Link Glucose Monitor can be automatically transmitted to the insulin pump for use in the pump's Bolus Wizard feature. Consumers or healthcare practitioners may also use the meter as a communication device to facilitate transfer of information between the pump and a personal computer.

For use by patients at home and clinicians in a medical office setting to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-511). MMT-7304 is intended for use in downloading device information when commanded by MMT-7311 operating on a PC and MMT-7304 is connected in line with the PC's serial port.

The Medtronic MiniMed Communication System is a data transfer system consisting of a hardware component designated by Medtronic MiniMed model number 7304 and a software component designated by model number 7311. The system is designed for use with Medtronic MiniMed infusion pump (model 511). The hardware component of the ComLink consists of a radio-frequency (RF) transceiver enclosed in a plastic housing and one female RS-232 compatible serial communications port. Data is downloaded via RF telemetry to transfer data from the pump to a personal computer. The Converts RF signals into RS-232 compatible electrical pulses, which are sent through a serial port to the PC.