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510(k) Data Aggregation

    K Number
    K073522
    Device Name
    VITRIFICATION KIT & VITRIFICATION WARMING KIT
    Manufacturer
    SAGE IN-VITRO FERTILIZATION INC.
    Date Cleared
    2008-10-10

    (301 days)

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

    SAGE IN-VITRO FERTILIZATION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vitrification Kit: These products are intended for ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. This kit is designed for use with Sage IVF's Vitrification Warming Kit (Ref # ART-8030) for optimal recovery of specimens. Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Sage IVF's Vitrification Kit (Ref # ART-8025) for Assisted Reproductive Technology (A.R.T.) procedures.
    Device Description
    There are five (5) solutions that comprise the two kits, Vitrification Kit and Vitrification Warming Kit. Vitrification Kit: Consists of two solutions, Equilibration Solution (ES) and Vitrification Solution (VS) that are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts. Equilibration Solution is used in preparation for freezing and contains dimethyl sulfoxide (DMSO) and ethylene glycol (EG). Vitrification Solution is to be used during cryostorage and contains DMSO and EG and sucrose. Vitrification Warming Kit: The three (3) warming solutions, 1.0 M Sucrose Warming Solution, 0.5 M Sucrose Warming Solution and MOPS Solution, are also intended for sequential use in the warming and recovery of cryopreserved human blastocysts.
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    K Number
    K053646
    Device Name
    INVITRO MATURATION MEDIA
    Manufacturer
    SAGE IN-VITRO FERTILIZATION INC.
    Date Cleared
    2006-07-14

    (196 days)

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

    SAGE IN-VITRO FERTILIZATION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    System for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons cannot or choose not to undergo conventional ovarian stimulation using drugs. Oocyte Washing Medium: This medium is used for washing immature oocytes contained within cumulus-oocyte complexes (COCs), collected from the follicles before maturation in culture. Oocyte Maturation Medium: This medium is used for maturation in culture of immature oocytes in an incubator. Embryo Maintenance: This medium is used for embryonic culture following insemination by intracytoplasmic sperm injection (ICSI).
    Device Description
    Oocyte Washing Medium is a balanced salt solution containing nutrients, amino acids and vitamins to maintain immature oocytes during their collection and washing. Oocyte Maturation Medium is a balanced salt solution containing nutrients, amino acids and vitamins for the in vitro culture of immature oocytes. Embryo Maintenance Medium is a balanced salt solution containing nutrients and amino acids for maintaining embryos in culture.
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