Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K031373
    Device Name
    IXL DIABETES MANAGEMENT SYSTEM
    Manufacturer
    INSULET CORP.
    Date Cleared
    2003-12-19

    (233 days)

    Product Code
    LZG
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSULET CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the continuous, subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Device Description
    The iXL Diabetes Management System has two (2) components: a Remote Controller, and an insulin infusion Pump, and two accessories; a fill syringe, and fill needle. The Remote Controller is a hand held, battery-operated device, with 9 functional buttons and an electro-luminescent (EL) backlit liquid crystal display (LCD). The device provides audio alarms, alerts and reminders. The Pump is activated and controlled exclusively through the use of the Remote Controller. The Pump and Remote Controller interact wirelessly using secure, radio frequency (RF). The Pump is a microprocessor controlled device. The Pump is worn directly on the body in the same manner and general locations as a conventional insulin infusion set. The Pump will leliver insulin based on the users custom programmed basal rate and bolus does for up to 72 houvs. The Pump provides audio alarms, alerts and reminders.
    Ask a Question

    Page 1 of 1