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510(k) Data Aggregation

    K Number
    K110518
    Device Name
    IBAG
    Manufacturer
    FUTURE PATH MEDICAL, LLC
    Date Cleared
    2011-06-24

    (121 days)

    Product Code
    KNX, EXS
    Regulation Number
    876.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE PATH MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to measure/ display collected urine volume. It detects fill level and temperature.
    Device Description
    iBag™ is a urine management system that includes bladder and temperature measurement for catheterized patients who desire to be fully mobile. · iBag™ provides accurate, real-time assistive data. It does this through use of a calibrated drainage bag integrated with a Future Path Medical sensor, a base transmitter unit called Wi-Mitter™ for wireless transmission of urine bag fill and bladder temperature information. Once the Wi-Mitter™ is snapped in place, the container is polled and the measurement of fluid level begins and this data is then transmitted to the patient, the care provider (an aid) a family member, or even to the hospital's base station. Data is transmitted via traditional data networking and may be interpreted and displayed on a user's laptop computer, and other types monitors. Since the data from the Wi-Mitter™ is time and date stamped, time of fill level may be automatically calculated, noted and threshold values used for fill level alarming.
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