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510(k) Data Aggregation

    K Number
    K233846
    Device Name
    Vitrification Solution Set and Warming Solution Set
    Manufacturer
    Date Cleared
    2024-08-27

    (267 days)

    Product Code
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECMPC, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vitrification Solution Set is intended for use in the virification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. The Warming Solution Set is intended for use in the thawing of vitrified occytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
    Device Description
    The Vitrification Solution Set and Warming Solution Set are intended for freezing and thawing oocytes and embryos for use in assisted reproductive technology (ART) procedures. The Vitrification Solution Set consists of two media components, the Equilibration Solution (ES) and the Vitrification Solution (VS). The Warming Solution Set consists of three media components, the Thawing / Warming Solution (TS), Diluent Solution (DS), and Washing Solution (WS). All media are provided in 1.8 ml polypropylene vials with a polyethylene cap. All media in both sets undergo aseptic filtration and are single-use only.
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