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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?
    Product Code :

    FLN

    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?
    Product Code :

    FLN

    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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    K Number
    K133870
    Device Name
    FLUID LEVEL MONITOR
    Date Cleared
    2014-04-24

    (125 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Product Code :

    FLN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fluid Level Monitor is a passive sensing device that alarms when the infusion fluid is low. The device provides both visual and audible alarms when preset condition is met. The Fluid Level Monitor is intended for low-fluid-level alarm use in any healthcare setting where gravity flow infirsed. The use of the device improves efficiency within a busy medical setting by providing healthcare personnel of the low-fluid-level status. LM771: 1-channel, DC battery power LM781: 1-channel, DC plug-in power LM785: 5-channel DC plug-in power
    Device Description
    Fluid Level Monitor is a passive sensing device that alarms when the infusion fluid level is low. Fluid Level Monitor provides both visual and audible alarms when preset condition is met. Fluid Level Monitor operates on DC power source. Fluid Level Monitor includes both main control unit and external sensor. There are status LEDs on the main control unit to display run, alarm and battery-low status. There is a buzzer on the main control unit to provide audible alarm. The external sensor is connected to the main control unit via shielded signal cable. The sensor can be clipped on the tubing to monitor fluid level.
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    K Number
    K080704
    Device Name
    LOW FLUID ALARM
    Manufacturer
    Date Cleared
    2008-04-17

    (36 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Product Code :

    FLN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Low Fluid Alarm System is a stand alone accessory for monitoring of liquid levels (standard saline solutions or other solutions with an aqueous base) in a reservoir. It is generally useable with rigid polycarbonate, flexible polyvinyl chloride (PVC) or glass reservoirs. If the level falls below a predetermined threshold visual and acoustical alarms appear. The Low Fluid Alarm System is designed for continuous arthroscopy operation in operating rooms and intensive care units. For the patient's safety the device is to be operated only by qualified medically-trained personnel and only with constant supervision.
    Device Description
    Not Found
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    K Number
    K050783
    Device Name
    ISSYS DRUG FLOW MONITOR
    Date Cleared
    2006-02-22

    (331 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Product Code :

    FLN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ISSYS Drug Flow Monitor is a passive monitoring device for gravity infusion. The unit uses a flow sensor to measure the amount of liquid through the infusion line and displays the flow rate and total volume administered to the patient. Flow rates and volumes are recorded, and if the flow rate or volume falls outside the preset range, both a visible and audible alarm is triggered. This monitor is indicated for use in where the flow rates are between 5 and 200 mL/hr. The accuracy of the monitor is +/- 20% at 5 mL/hr and +/- 5% at 200 mL/hr. For use with IV drug solutions administered by gravity. WARNING: DO NOT USE WITH BLOOD OR BLOOD PRODUCTS.
    Device Description
    The ISSYS Drug Flow Monitor is a passive monitoring device for gravity infusion. The unit uses a flow sensor to measure the amount of liquid through the infusion line and displays the flow rate and total volume administered to the patient. Flow rates and volumes are recorded, and if the flow rate or volume falls outside the preset range, both a visible and audible alarm is triggered.
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    K Number
    K060123
    Device Name
    LEVELERT II FLUID LEVEL SENSOR
    Date Cleared
    2006-02-14

    (27 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Product Code :

    FLN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Smith & Nephew LEVELERT II Fluid Level Sensor is intended to weigh a bag of irrigation fluid and signal operating room personnel when a pre-determined amount of fluid remains.
    Device Description
    The Levelert II is a irrigation fluid bag level sensing device designed to provide the user with fluid level feedback at pre-determined values. The pre-determined values are selected by the user. The Levelert II is a stand-alone DC battery powered, nonrechargeable device that is used in arthroscopic procedures.
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    K Number
    K030136
    Device Name
    DRIP ALERT
    Manufacturer
    Date Cleared
    2003-04-07

    (83 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Product Code :

    FLN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Drip Alert device is a passive device that measures time between intravenous drops and sounds an alarm when the time between drops falls outside an acceptable range due to air in the line, occlusion, low or empty fluid in the solution bag, high or low flow rate, and low battery. The Drip Alert device is intended to be used as a supplementary monitor with a standard IV administration set such that an alarm sounds when the drip rate in the drip chamber of the administration set falls outside a preselected range of acceptable drip rate deviation. The deviation in the drip rate may be due to air in the IV line, occlusion, excessive movement by the patient or displacement of the IV catheter.
    Device Description
    The Drip Alert device is a passive device that measures time between intravenous drops and sounds an alarm when the time between drops falls outside an acceptable range due to air in the line, occlusion, low or empty fluid in the solution bag, high or low flow rate, and low battery. The Drip Alert device does not have a pump or clamping mechanism. It uses a processor to perform calculations and measurements and has a flow meter. It is powered by 2-AAA batteries with a typical 30 day life. It is a Class II Device.
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    K Number
    K022248
    Device Name
    STRYKER L3 HYDROLERT
    Manufacturer
    Date Cleared
    2002-08-06

    (25 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Product Code :

    FLN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MT Alert Infusion Monitor is intended for use in any healthcare setting where gravityflow infusions are utilized. The Stryker L3 Hydrolert is intended to monitor irrigant levels primarily during arthroscopic procedures and to alert operating room personnel of a low irrigant fluid level condition. It will offer both increased efficiency in arthroscopic procedures and universal compatibility with both arthroscopic pump and gravity fluid management systems. It is intended for use with saline solution or any other standard irrigant. It is not intended for use as an intravenous infusion monitor. The alarm is designed to be reusable.
    Device Description
    The MT Alert Infusion Monitor is a passive weighing device that alarms when the infusion bag is near-empty. The alarm point can be set by the user. In addition, MT Alert may also assist in monitoring fluid bolus administration. MT Alert will alarm when a prescribed bolus of fluid has been taken from the infusion bag. MT Alert provides various audio and visual alarms. MT Alert operates from common alkaline batteries and mounts on common poles and rods.
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    K Number
    K013121
    Device Name
    MT ALERT INFUSION MONITOR
    Date Cleared
    2001-10-15

    (27 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Product Code :

    FLN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MT Alert Infusion Monitor is intended for use in any healthcare setting where gravity-flow infusions are utilized.
    Device Description
    The MT Alert Infusion Monitor is a passive weighing device that alarms when the infusion bag is near-empty. The alarm point can be set by the user. In addition, MT Alert may also assist in monitoring fluid bolus administration. MT Alert will alarm when a prescribed bolus of fluid has been taken from the infusion bag. MT Alert provides various audio and visual alarms. MT Alert operates from common alkaline batteries and mounts on common poles and rods.
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    K Number
    K973025
    Device Name
    FLUID CENTURION (4-100-00)
    Date Cleared
    1997-11-20

    (98 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Product Code :

    FLN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    THE NORTECH FLUID CENTURION UNIT IS INDICATED FOR USE WHERE POST-OPERATIVE IRRIGATOIN IS INDICATED.
    Device Description
    The Fluid Centurion is designed to be used where post-operative irrigation is required. The Fluid Centurion is comprised of a battery operated, stand alone unit that is substantially equivalent in design, materials, and intended use to the Smith & Nephew Dyonics Levelert™ Fluid Level Sensor.
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