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510(k) Data Aggregation

    K Number
    K954769
    Device Name
    BIEGLER BW385L BLOOD & INFUSION WARMER
    Manufacturer
    BIEGLER MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-08-08

    (297 days)

    Product Code
    LGZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIEGLER MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biegler BW385L Blood and Infusion Warmer has the same intended use as several devices now marketed in the U.S. The DW1000, Baxter, the HotlineR1, Level 1; the FloTemR2, DataChem and the FenwalR3, Baxter are all used to heat infusate.
    Device Description
    The Biegler BW385L Blood & Infusion Warmer is designed to reduce complications associated with the infusion of blood and other liquids that are cooler than normal body temperature. The BW385L warms the fluid by means of a metal Heat Exchanger which is adjacent to an I.V. Tubing Extension Set through which the fluid to be heated flows. The cylindrical Heat Exchanger has a series of grooves; the Extension Set tubing is 'wrapped' around the Exchanger and into these grooves. The BW385L operates on a 120 volt (or where required 220 Volt) A.C. power source and is controlled by an on-off switch on the plastic face of the instrument. Above the on-off switch is an LED temperature monitor. The BW385L Blood & Infusion Warmer weighs 2.5 Kg. and is equipped with a dual knob clamp at the back of the instrument for I.V. pole attachment. The infusate is warmed to approximate body temperature as it travels a path around the constantly monitored and regulated Heat Exchanger. The BW385L is UL / C-UL approved and units placed to date have received special CSA inspection certification.
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