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510(k) Data Aggregation

    K Number
    K172242
    Device Name
    DripAssist Plus
    Manufacturer
    Date Cleared
    2018-05-25

    (303 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shift Labs, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DripAssist Plus is a device intended to be used with gravity infusions as a supplementary monitor the flow of fluid through a compatible drip chamber. The device is intended to be used with single-use intravascular administration sets uniquely identified as "compatible with DripAssist Plus." Sensors measure the flow rate and calculations are performed to convert the drip rate to mL/hr measurement and total volume. An alarm is available to alert the user if the drip rate deviates from the set infusion rate setting controlled through the IV administration set.
    Device Description
    The DripAssist Plus device is intended to be used as a supplementary monitoring system for monitoring the flow rate of intravenous fluids. DripAssist Plus is a passive device. It does not control the flow rate of fluids passing through a drip chamber. The device operates by monitoring the drops through the drip chamber of a compatible single-use intravascular administration set that is inserted into a mechanical attachment mechanism on the DripAssist Plus. By tracking the intervals between drops, the device calculates the flow rate through the chamber and displays the flow rate on an LCD screen. The device operates by tracking drops using an infrared emitter and detector positioned on opposite sides of a well wherein the drip chamber is situated. There is an alarm functionality that can be activated once a desired flow rate, or "set point," is reached. The alarm, when activated, will sound when the flow rate deviates a fixed percentage from the "set point." The device can be used with compatible drip sets of 10, 15, 20, or 60 gtt/mL. The device is powered by one AA battery. The device can display the flow rate in drops per minute or mL per hour. The unit of measurement being displayed can be changed while the device operates. The device can also display the total volume that has dispensed through the drip chamber. The device is designed to be used with drip rates slow enough to be calculated by the human eye; a steady stream of fluid is outside the operating parameters.
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    K Number
    K150687
    Device Name
    DripAssist
    Manufacturer
    Date Cleared
    2015-10-13

    (210 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shift Labs

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DripAssist is a device intended to be used as a supplementary monitor that measures the flow of fluid through the drip chamber of a standard IV administration set. Sensors measure the flow rate and calculations are performed to convert the drip rate to ml/hr measurement and total volume. An alarm is available to alert the drip rate deviates from the infusion rate setting controlled through the IV administration set.
    Device Description
    The DripAssist device is intended to be used as a supplementary monitoring system for monitoring the flow rate of intravenous fluids. The DripAssist is a passive device. It does not control the flow rate of fluids passing through a drip chamber. The device operates by monitoring the drops through the drip chamber of a standard IV administration set. By tracking the intervals between drops, the device calculates the flow rate through the chamber and displays the flow rate on an LCD screen. The device operates by tracking drops using an infrared emitter and detector positioned on opposite sides of a well wherein the drip chamber is situated. There is an alarm functionality that can be activated once a desired flow rate, or "set point," is reached. The alarm, when activated, will sound when the flow rate deviates from a fixed percentage from the "set point."
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