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510(k) Data Aggregation

    K Number
    K050524
    Device Name
    EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
    Manufacturer
    MARDA MEDICAL, INC.
    Date Cleared
    2005-09-14

    (196 days)

    Product Code
    IRQ
    Regulation Number
    890.5950
    Why did this record match?
    Product Code :

    IRQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZ-IV Medical Pad Warming Unit is intended to warm alcohol and povidone iodine skin cleansing pads for use in gaining venous access during intravenous fluid and / or medication administration and to facilitate phlebotomy procedures.
    Device Description
    The EZ-IV Medical Pad Warming Unit, is a compact, portable, tabletop size medical device, used to warm factory sealed medical prep pads (alcohol and povidone iodine), with a pre-set maximum temperature of 55° C. A lid covers the unit to minimize any heat loss from the medical pads. Inside the unit are four individual compartments, in which the sealed pads are placed. Each compartment has it's own, inner lid. The front of the device has a membrane keypad to control the device function.
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