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510(k) Data Aggregation

    K Number
    K130554
    Device Name
    REDSENSE ALARM SYSTEM
    Manufacturer
    REDSENSE MEDICAL AB
    Date Cleared
    2013-11-22

    (263 days)

    Product Code
    ODX
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    ODX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment. The device includes a blood sensor incorporated into a sensor patch. The sensor monitors potential blood leakage from the venous needle blood access via a light signal and will alarm if blood leakage is detected by the device's sensor.
    Device Description
    Redsense Medical provides a system for monitoring the blood access during haemodialysis consisting of an alarm unit and a sensor connected to a specifically developed patch. The Redsense Patch uses integrated optic fibers to detect blood leakage from wounds. The optic fiber is connected to the sensor and alarm unit. If blood leakage occurs during haemodialysis, the patch surrounding the vein needle registers the event and changes a light signal to the alarm unit. This immediately activates a light and an alarm signal. Thus if a vein needle comes out of place extensive blood leakage is prevented.
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    K Number
    K103242
    Device Name
    REDSENSE-ALARM UNIT AND SENSOR
    Manufacturer
    REDSENSE MEDICAL AB
    Date Cleared
    2011-02-10

    (100 days)

    Product Code
    ODX
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    ODX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing continuous hemodialysis treatment up to 8 hours in the clinical settings. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch.
    Device Description
    Redsense is a system for monitoring the vein needle during hemodialysis. Redsense consists of an alarm unit and optical sensor incorporated into an adhesive patch. The patch with the sensor is placed over the vein needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm.
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    K Number
    K092955
    Device Name
    REDSENSE-HOME USE
    Manufacturer
    REDSENSE MEDICAL AB
    Date Cleared
    2010-05-10

    (227 days)

    Product Code
    ODX
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    ODX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment up to 5 hours at home or in the clinical setting. The device includes a blood sensor incorporated into an adhesive dressing. The sensor monitors potential blood leakage from the needle puncture via an infrared light and will alarm if needle dislodgement or blood leakage is detected. All use must be administrated under physician's prescription, and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.
    Device Description
    Redsense Home Use is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consists of an alarm unit and optical sensor incorporated into an adhesive patch. The patch with the sensor is placed around the vein needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm.
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    K Number
    K071013
    Device Name
    REDSENSE
    Manufacturer
    REDSENSE MEDICAL AB
    Date Cleared
    2007-10-18

    (191 days)

    Product Code
    ODX
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    ODX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing continuous hemodialysis treatment up to 5 hours in the clinical setting. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch.
    Device Description
    Redsense is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consists of an alarm unit and infrared sensor incorporated into an adhesive patch. The patch with the sensor is placed around the vein or arterial needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm.
    Ask a Question

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