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510(k) Data Aggregation

    K Number
    K250345

    Validate with FDA (Live)

    Device Name
    Medline Bag Decanter
    Manufacturer
    Medline Industries, LP.
    Date Cleared
    2025-10-24

    (260 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K182819
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.

    Device Description

    The Medline Bag Decanter is a non-pyrogenic, single use, disposable device, which is supplied sterile. The device comprises of a one-piece transfer device with protective flexible caps at either end. The device is an injection molded hollow tube with a spiked end used to access the source container and withdraw fluid. The spike component is designed with a built-in splash guard. The device is designed for use in transferring IV fluids/medication from a bag to an IV fluid administration device.

    AI/ML Overview

    N/A

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