Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213293
    Device Name
    V-HEPES PLUS
    Date Cleared
    2022-09-14

    (348 days)

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

    Vitromed Langenfeld

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    V-HEPES PLUS is intended for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity.
    Device Description
    V-HEPES PLUS is a medium for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity. The medium is aseptically filtered and provided in a volume of 100 mL in pre-sterilized PETG bottles. V-HEPES PLUS has a shelf-life of 12 months when stored at 2-8°C and can be used for up to seven days after bottle opening.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1