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510(k) Data Aggregation

    K Number
    K251139

    Validate with FDA (Live)

    Device Name
    KabiHelp® Uno; KabiHelp® Advance plus
    Manufacturer
    Fresenius Kabi AG
    Date Cleared
    2026-01-09

    (270 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K210749
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KabiHelp® Bag is an empty container to be filled with components of parenteral nutrition and parenteral nutrition related medication to be administered to the patients using an intravascular administration set. Parenteral nutrition and parenteral nutrition related medication transfer in and out of the container is done using aseptic technique.

    Device Description

    The KabiHelp® Bag is an empty plastic container to be filled with components of parenteral nutrition and parenteral nutrition related medication to be administered to patients using an intravascular administration set. It is designed to be used with KabiHelp Pro Compounding System and KabiHelp Transfer Sets and Accessories.

    Filling of the bags takes place in an aseptic environment. The bags are available in monolayer or multilayer models in various volumes.

    All KabiHelp bags are equipped with three port types: (1) a filling port suitable for the KabiHelp Transfer Sets, (2) an injection port for manual injection of additives, and (3) an administration port for infusion therapy.

    AI/ML Overview

    N/A

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