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510(k) Data Aggregation

    K Number
    K251733
    Device Name
    Fluido® AirGuard System
    Manufacturer
    The Surgical Company International BV (as TSC Life)
    Date Cleared
    2025-09-04

    (90 days)

    Product Code
    LGZ
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K060939,K141654
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K060939

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    • Infusion of crystalloid, colloid or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery.
    • Infusion of warmed fluid to patients with the ability to prevent hypothermia.

    Device Description

    The Fluido® AirGuard System (FAS) is a pressurized infusion system intended for warming blood and fluids prior to administration to help prevent perioperative hypothermia. The FAS uses infrared heating technology to safely warm blood and fluids; the system detects air to prevent it from entering the patient.

    The FAS consists of the Fluido Pressure Chambers, Fluido Blood and Fluid Warmer, Fluido AirGuard, Fluido Compressor, Fluido IV Pole, and Fluido Single-Use (Disposables): Standard Set and Trauma Set.

    AI/ML Overview

    N/A

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