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The Symphony System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood. The Symphony Pump is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. 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 System combines the use of an insulin pump and a blood glucose meter for the treatment of insulin requiring diabetes. The insulin pump, Symphony Pump, operates as a stand alone device to deliver insulin through an infusion set placed subcutaneously. The blood glucose meter, Symphony Meter Remote, operates as a stand alone device to measure blood glucose concentrations. 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 Animas ezManager® MAX Diabetes Management Software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or healthcare professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.

The Animas ezManager MAX Diabetes Management Software, installed onto a patient's or healthcare professional's personal computer, allows downloading of information to and from Animas insulin pumps and specified commercially available blood glucose meters. The software displays downloaded historical data stored in the pump and blood glucose meter such as basal/bolus deliveries and blood glucose measurements. The data can be displayed in reports and logs to facilitate trending and diabetes management.

The Animas ezManager Plus diabetes management software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or health care professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information. The Animas ezManager Plus will also allow download of information from Animas pumps and commercially available blood glucose meters to a hand-held electronic device for display of the information. The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on health care professional prescribed settings and user entered data.

The Animas ezManager Plus diabetes management system is software that is loaded onto a patient's or health care professional's personal computer to allow for downloading information from Animas insulin pumps and specified commercially available blood glucose meters. The system allows for users to view data stored in the pump and meter history such as basal deliveries, bolus deliveries and blood glucose measurements. The data can be displayed in numerous formats and configurations to facilitate trending and better diabetes management. The Animas ezManager Plus diabetes management system also allows for Animas pump users to upload personal setting information to their pump. Personal setting information includes basal programs and rates, insulin to carbohydrate ratios, insulin sensitivity factors, target blood glucose ranges, and when available pump food database information (food, serving size and carbohydrate information). This feature allows users the convenience of programming and saving all of this information on their personal computers. Once the information is uploaded to the pump, the user is prompted to verify the active basal program before initiating therapy. For Animas pumps the download and upload is completed using an IR dongle and the IR window on the back of the pump. For the specified meters, the download is accomplished by using the manufacturer specified connection cables.

The Animas Model IR1250 Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients.

The Animas Model IR1250 Insulin Infusion Pump is an external syringe pump and delivery system that provides subcutaneous delivery of insulin for patients with diabetes mellitus who would benefit from a continuous insulin infusion process. The Model IR1250 is used with any insulin infusion set which incorporates a luer style connection. The pump incorporates serial communications via an infrared (IR) interface with accessories which include the Animas IR to RS-232 serial interface adaptor (the "dongle"), the Animas IR1200 cradle to hold the pump and the Animas ezManager Plus software for the user's personal computer. As with the IR1200, this connection allows the user and/or the physician to transfer (download) data stored in the pump to the personal computer where it may be displayed, printed and saved. With the IR1250 this same connection will allow the user to program the pump, via the PC with ezManager Plus software, with selected user pump settings (basal program, bolus limits, etc.) and non-operational, personalized information including user selection of names for basal settings and musical tunes for initial alert/reminder warnings prior to the present pump alert/warning sounds. Also available to the user is the option to use a PC with ezManager Plus software, to upload and/or modify selected food items and related carbohydrate information, for storage in, and reference/use directly from, pump memory. The pump is intended for multiple years of use. To hold the insulin for subcutaneous delivery, Animas provides sterile, single use, disposable insulin cartridges for use specifically with the IR1200 series pumps. As with the IR1200, the IR1250 will deliver a prescribed dosage of insulin as a single programmable bolus or at multiple programmable basal rates. The system will also provide set up information, dosage history, alarms, error and warning messages, device status, and self test capabilities.

The Animas Model IR 1200 Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. This device is intended for home use and is a prescription device.

The Animas Model IR 1200 Insulin Infusion Pump is an external syringe pump and delivery system that provides subcutaneous delivery of insulin for patients with diabetes mellitus who would benefit from a continuous insulin infusion process. The Model IR 1200 is used with an infusion set, e.g., the Animas ezSet™ The pump incorporates serial communications via an infrared (IR) interface. The user may download records from the pump for Daily Totals, Alarm History, Bolus History, as well as Basal Rate programs and Pump Settings. The pump is intended for multiple years of use and the insulin syringe is a sterile, single use disposable manufactured for Animas. The system will deliver a prescribed dosage of insulin as a single programmable bolus or at multiple programmable basal rates. The system will also provide set up information, dosage history, alarms, error and warning messages, device status, and self test capabilities.

The Animas ezManager Plus is indicated for use as an accessory to the Animas IR1000 insulin pump and a number of commercially available blood glucose meters to download data from these devices to a patient's or a physician's personal computer where it may be displayed, printed, and saved. The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on physician prescribed settings and user entered data.

The Animas ezManager Plus diabetes management software is intended for a Microsoft Windows based personal computer or a Palm handheld organizer. The ezManager Plus allows the user to download, view, print, and save data from a number of commercially available glucose meters and the Animas IR1000 Insulin Infusion Pump. It also calculates an insulin or carbohydrate dosage based physician prescribed settings and data entered by the user. This software was developed using a Borland Delphi integrated development environment using an MS Access database structure and ActiveX Data Objects database connections. The synchronization dynamic library is totally compliant with the Palm Operating System (OS) Conduit requirement and was developed using Microsoft Visual C++ and the Palm OS Software Development Kit.

The Animas ezSerter™ Infusion Set Inserter is intended to aid in the insertion of the Animas ezSet™ infusion sets. This device is intended for home use and is a prescription device.

The Animas ezSerter™ Infusion Set Inserter is a simple device for automatically inserting the cannula of the Animas ezSef™ angled infusion sets subcutaneously. The inserter is composed of several molded plastic pieces and stainless steel springs. An elongated molded plastic housing acts as a handle and a quide for an internally mounted spring-loaded carrier. An opening in the proximal end of the carrier accepts and retains the handle of the introducer needle hub.

The Animas Model R1000 IR Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. The accessories to the Model R1000 IR, the Animas RS-232 IR serial interface adator (the "dongle"), the Animas R1000 IR cradle to hold the pump and the Animas ezLink™ software are intended to transfer data stored in the pump to the personal computer of a patient or a physician, where it may be displayed, printed, and saved. This device is intended for home use and is a prescription device.

The Animas Model R1000 IR Insulin Infusion Pump is an external syringe pump and delivery system that provides subcutaneous delivery of insulin for patients with diabetes mellitus who would benefit from a continuous insulin infusion process. The Model R1000 IR is used with an infusion set, e.g., the Animas ezSet™. The pump incorporates serial communications via an infrared (IR) interface. The Animas RS-232 IR serial interface adaptor (the "dongle"), the Animas R1000 IR cradle to hold the pump, and the Animas ezLink™ software for the user's personal computer are the remaining components of the system. The ezLink™ software will allow the user to download records from the pump for Daily Totals, Alarm History, Bolus History, as well as Basal Rate programs and PUMP Settings. A leather case and a belt clip are provided as accessories. The pump is intended for multiple years of use and the insulin syringe is a sterile, single use disposable manufactured for Animas. The system will deliver a prescribed dosage of insulin as a single programmable bolus or at multiple programmable basal rates. The system will also provide set up information, dosage history, alarms, error and warning messages, device status, and self test capabilities.

The Animas EZ Set Infusion set is intended to provide infusion of medicine, including insulin, from an external infusion pump. This device is intended for home use and is a prescription device.

The Animas EZ Set Infusion Set is an infusion adminstration set with the proximal end connecting to a medicine reservoir syringe within an infusion pump and the distal end inserted in the subcutaneous itssue of a user. The device consists of two components, an infusion site assembly and a tubing connector assembly. The infusion site assembly consists of a cannula housing with a disposable insertion hub assembly. The main body of the cannula housing has a thin self-adhesive pad for attachment to the skin. A soft flexible 22 gauge cannula extends below the flat bottom of the housing to penetrate the skin at a slight angle. A detachable insertion needle assembly is intitially connected to the cannula housing assembly to insert the soft flexible cannula subcutaneously. It is then removed and replaced by the needle hub assembly to deliver medication. An elastomeric septum seals the entrance to the cannula when the needle hub assembly is removed. The tubing connector assembly consists of a length of flexible plastic tubing made from polyvinyl chloride with a co-extruded polyethylene liner. The tubing is attached to a female Luer Lock connector at one end and a short needle mounted in the main body of the needle hub at the opposite end. The main body provides a means to align and attach the needle hub to the cannula housing assembly by means of a quick release connector. When the cannula housing and the needle hub are connected, the needle penetrates the septum allowing medication to flow from the pump through the flexible tubing, the needle, and the cannula into the patient's body. The needle hub assembly may be easily released from the cannula housing by squeezing the resilient side members deflecting the retaining band above a bump on the cannula housing. This allows the needle housing to slide freely off the cannula housing. The quick release connector allows the user to temporarily disconnect the tubing at the insertion site for activities such as dressing or bathing. In addition to complete administration sets, infusion site sets without the tubing i and quick release connector will also be available.

The Animas Corporation R1000 Series Insulin Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of Type 1 and certain instances of Type 2 diabetes mellitus. The pump is indicated for use in diabetics who have good personnal hygiene, who have established control over their blood glucose and who do not have unpredictable or large variations in blood glucose levels. The Animas Corporation R1000 Series Insulin Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in insulin dependent patients. This device is intended for home use and is a prescription device.

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