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    K Number
    K150484
    Device Name
    Penguin In-Line Warmer
    Manufacturer
    Creche Innovations
    Date Cleared
    2015-07-09

    (135 days)

    Product Code
    LGZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    Creche Innovations

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Penguin In-Line Warmer is an electrically powered dry warmer which supplies external heat to the plastic tubing of enteral nutrition administration sets.
    Device Description
    The Penguin In-Line Warmer is an external dry-heat thermal warmer. The Penguin In-Line Warmer warms nutritional feedings for patients being fed via a gastrointestinal tube.
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