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510(k) Data Aggregation

    K Number
    K140387
    Device Name
    Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
    Date Cleared
    2014-12-23

    (312 days)

    Product Code
    Regulation Number
    868.1890
    Why did this record match?
    Product Code :

    PDT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BRDSS-C is indicated for use in the care of adult patients and adolescent patients 17 years of age or older who weigh 40kg (88lbs) or more with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for fluid recommendations. The BRDSS-C is intended to be initiated within 24 hours of the burn incident and completed by 72 hours post burn. The BRDSS-C is not indicated for use in patients who are less than 17 years of age.
    Device Description
    The Burn Resuscitation Decision Support System – Clinical (BRDSS-C) is a burn decision support software application for assisting healthcare professionals in managing fluid resuscitation of burn patients during the initial 24 - 72 hours post burn. The system provides hourly (or half-hour) fluid calculations and recommendations for patients with 20% or greater Total Body Surface Area (TBSA) burn injuries, in addition to providing users with a graphical user interface to display volume status, Intake and Output (I/O) volumes, and other relevant fluid balance information.
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    K Number
    K121659
    Device Name
    BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
    Manufacturer
    Date Cleared
    2013-04-18

    (317 days)

    Product Code
    Regulation Number
    868.1890
    Why did this record match?
    Product Code :

    PDT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Burn Resuscitation Decision Support System (BRDSS) is indicated for use in the care of adult patients with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for hourly fluid recommendations. The BRDSS is intended to be initiated within 24 hours of the burn incident and ending by 72 hours post burn.
    Device Description
    The BRDSS is a fluid calculator for use in the care of seriously burned patients. It is used to calculate the next dose of fluid for patients.
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