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510(k) Data Aggregation

    K Number
    K252636

    Validate with FDA (Live)

    Date Cleared
    2025-11-18

    (90 days)

    Product Code
    Regulation Number
    880.5725
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device can be used with the following products:

    • Plasma
    • Packed red blood cells
    • Crystalloid intra venous (IV) fluids
    • Synthetic Colloid intra venous (IV) fluids

    The system is indicated to be used in a healthcare environment to help prevent hypothermia. The devices can be used in the full clinical environment. The Fluido Compact System can be used in adult and pediatric patients (weighing 3.5 kg or more) who require fluid warming prior to the administration of blood products or IV fluids to help prevent hypothermia. The system is intended to be used by healthcare professionals, e.g., nurses, medical specialists, and doctors.

    Device Description

    The Fluido Compact System is a Blood and Fluid Warming System. The system is suitable for low to moderate flow applications. For high flow applications (higher than 100 ml/min for more than 5 minutes) the use of a high flow system is recommended.

    The Fluido Compact System uses conduction heating technology to warm blood and fluids. Based on in-line sensors, the system calculates the energy required to safely warm the infusates.

    The Fluido Compact System can be used with patients who require fluid warming prior to the administration of blood products or IV fluids, to help prevent hypothermia. The system is intended to be used in a healthcare environment by healthcare professionals, e.g. nurses, medical specialists, doctors. Only medical professionals shall interact with the system. The devices must only be used on the order of a physician.

    AI/ML Overview

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