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510(k) Data Aggregation

    K Number
    K190152
    Device Name
    Vit Kit- Freeze NX and Vit Kit- Warm NX
    Manufacturer
    FUJIFILM Irvine Scientific, Inc.
    Date Cleared
    2019-06-21

    (142 days)

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

    FUJIFILM Irvine Scientific, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vit Kit - Freeze NX (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MI) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. Vit Kit - Warm NX (Vitrification Warm Kit) is intended for use in the thawing of vitrified occytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
    Device Description
    The five media products that comprise the two kits, Vit Kit - Freeze NX and Vit Kit -Warm NX, consist of a basal media of Continuous Single Culture Medium (CSCM) which utilizes MOPS, HEPES and sodium bicarbonate buffers, 20% (v/v) DSS, 10μg/mL gentamicin and varying levels of cryoprotectants, including dimethyl sulfoxide (DMSO), trehalose, and ethylene glycol (EG). The two freeze media in the Vit Kit – Freeze NX are intended to be used sequentially for the preparation and cryopreservation of oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. The three media in the Vit Kit - Warm NX are intended for sequential use in the thawing and recovery of cryopreserved oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
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