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510(k) Data Aggregation

    K Number
    K132870
    Device Name
    Origio Gas Line Filter
    Manufacturer
    Date Cleared
    2014-05-07

    (236 days)

    Product Code
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIGIO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ORIGIO® Gas Line Filter is intended for the reduction of volatile organic compounds (VOC's) and particulate contaminants from supply gas lines to incubators and work stations that are used in assisted reproduction technologies and/or In vitro fertilization procedures.
    Device Description
    The Origio Gas Line Filter combines a High Efficiency Particulate Air (HEPA) Filter Media and an Activated Carbon Media Filter which is impregnated with Potassium Permanganate (KMNO4). The 1.5", 0.5um Glass Fiber HEPA Media is designed to remove particulates from the supply gas, №2, СО₂ or TriGas (N₂, CO₂ and O₂ ) blend which is commonly used in IVF Incubators and other IVF work stations. The 3.5" Potassium Permanganate – Impregnated Activated Carbon Fiber Felt Media is designed to remove Volatile Organic Compounds (VOC's) from the supply gas provided to the IVF Incubator/Work Station. The HEPA Filter Media and the Activated Carbon Filter Media are encased in a polypropylene outer shell creating a capsule for the filtration of the medical supply gas. The Origio Gas Line Filter is designed to be installed between the supply gas and the IVF Incubator/Work station utilizing the integrated ¼" male and ¼" female quick- connections. Quick disconnect "intake and output fittings" and clamps are provided along with a magnetic holding bracket for easy installation on to the supply gas line. The Origio Gas Line Filter is provided non-sterile and is individually vacuum packed in a double poly bag.
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