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510(k) Data Aggregation

    K Number
    K070135
    Device Name
    VITRIFREEZE MEDIUM; VITRITHAW MEDIUM
    Manufacturer
    Date Cleared
    2007-08-16

    (212 days)

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

    FERTI PRO N.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitriFreeze Media are intended for ultra-rapid freezing of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. VitriThaw media are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing for Assisted Reproductive Technology (A.R.T.) procedures.
    Device Description
    The seven (7) media that comprise the two (2) VitriFreeze and VitriThaw media are all based upon a modified formulation of other media. The three (3) freeze media in VitriFreeze are intended for use sequentially and are named Pre-incubation medium, VitriFreeze Medium 1 and VitriFreeze Medium 2. These media are used for preparation for and cryopreservation of human blastocysts. Preincubation medium is used to equilibrate the blastocysts. VitriFreeze, Medium 1 is used for the preparation to the vitrification. VitriFreeze, Medium 2 is the actual vitrification medium that is used during cryostorage. The four (4) thawing media in VitriThaw are also for sequential use in the thawing and recovery of cryopreserved human blastocysts. VitriThaw media includes VitriThaw Medium 1, VitriThaw Medium 2, VitriThaw Medium 3, VitriThaw Medium 4
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    K Number
    K053494
    Device Name
    OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
    Manufacturer
    Date Cleared
    2006-03-23

    (98 days)

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

    FERTI PRO N.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching. Gradient System is used for separation and purification of human sperm for assisted reproduction procedures. SpermFreeze is intended to be used as a cryopreservation medium for human sperm.
    Device Description
    Oil For Tissue Culture is a colorless liquid paraffin. Gradient System is a solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SpermFreeze is a HEPES buffered freezing medium for use with human Sperm. It contains 0.4 % human serum albumin.
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