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510(k) Data Aggregation

    K Number
    K232107
    Device Name
    °M Warmer System
    Manufacturer
    MEQU A/S
    Date Cleared
    2024-05-31

    (322 days)

    Product Code
    LGZ, BSB
    Regulation Number
    880.5725
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    Applicant Name (Manufacturer) :

    MEQU A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.
    Device Description
    The °MEQU °M Warmer System consists of three components: - a single-patient use, disposable warmer unit - a multi-patient, reusable, rechargeable battery pack for powering the warmer - a reusable charger for recharging the battery pack. The warmer contains a sterile fluid path with standard Luer lock connectors allowing it to be connected in the infusion fluid line. The fluid path includes a parylene coated aluminium heating chamber in which fluids passing through the warmer are heated. Heat is generated using resistive heating elements, using power supplied by the rechargeable battery pack. The warmer contains the electronics and software to control the temperature of the chamber and thus the temperature of the outgoing fluid. Remaining power in the battery pack is indicated to the user during use. When depleted, the battery pack can be re-charged using the charger.
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