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510(k) Data Aggregation

    K Number
    K242640
    Device Name
    FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
    Manufacturer
    FertiPro Nv
    Date Cleared
    2025-05-30

    (269 days)

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

    FertiPro Nv

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FertiCult™ Flushing medium are intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult™ Flushing medium can also be used human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity. The medium is NOT intended for oocyte pick-up and follicle flushing. FertiCult Flushing medium is used during assisted reproductive Technology (ART) procedures of patients and couples undergoing infertility treatments.
    Device Description
    FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult Flushing media can also be used for human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity. The base formulation contains Water, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Sulphate Heptahydrate, Sodium Dihydrogen Phosphate Dihydrate, Sodium Pyruvate, Glucose Monohydrate, Sodium Lactate, Sodium hydrogen carbonate, HEPES, Human Serum Albumin. A FertiCult Flushing media variant contains Phenol red and Gentamicin. The products can be used up to 7 days after opening, when sterile conditions are maintained, and the products are stored at 2-8°C.
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    K Number
    K221547
    Device Name
    InActiv Blue
    Manufacturer
    FertiPro NV
    Date Cleared
    2024-06-11

    (746 days)

    Product Code
    QBD
    Regulation Number
    866.2950
    Why did this record match?
    Applicant Name (Manufacturer) :

    FertiPro NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InActiv Blue is intended for the stabilization, transportation and inactivation of upper respiratory specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at refrigerated (2-8°C) or ambient temperatures (20-25°C). SARS-CoV-2 RNA in the specimens is stabilized for 7 days at these specified temperatures. Specimens collected and stored in an InActiv Blue collection tube are suitable for use with legally marketed molecular diagnostic devices.
    Device Description
    InActiv Blue is a virus-inactivating and lysis solution that abrogates the infectious potential of the collected material without affecting the integrity of the RNA. Two milliliters of InActiv Blue solution are provided in a polypropylene flat bottom collection tube with a high-density polyethylene (HDPE) cap (product code IB TUB). The device is non-sterile, single use. Secondary Packaging for the collection tube configuration includes racks of 50 collection tubes and cardboard boxes with either 400 or 1200 collection tubes. Sample types intended for collection with the device include upper respiratory swab samples. Swabs are not provided with the InActiv Blue collection tubes. The active components of the InActiv Blue solution are guanidine thiocyanate, Nlauroylsarcosine sodium salt and EDTA. These components are formulated in a sodium phosphate buffered solution containing methylene blue.
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