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    K Number
    K133799
    Device Name
    THERMEDX FLUID MANAGMENT SYSTEM
    Manufacturer
    THERMEDX LLC
    Date Cleared
    2014-06-20

    (189 days)

    Product Code
    HIG, HRX, LGZ
    Regulation Number
    884.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMEDX LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermedx Fluid Management System is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
    Device Description
    The Thermedx device is a fluid management system intended for surgical applications. The device consists of a main unit and disposable tubing sets. A rolling stand-mounted device houses infrared fluid heating technology and a peristaltic fluid pump with closed-loop controls. The Thermedx monopolar electrocautery probes are an optional accessory for electrosurgical cutting and coagulation.
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