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510(k) Data Aggregation

    K Number
    K241095
    Device Name
    ARTSMedia Semen Wash Medium
    Manufacturer
    ARTSMedia Denmark ApS
    Date Cleared
    2024-12-18

    (240 days)

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

    ARTSMedia Denmark ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
    Device Description
    ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination). ARTSMedia Semen Wash Medium consists of physiological salts, energy substrates, buffering agents, Gentamicin Sulphate, and water. Furthermore, ARTSMedia Semen Wash Medium is aseptically filtered and provided in a volume of 20 mL. 50 mL. and 100 mL in pre-sterilized glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The ARTSMedia Semen Wash Medium is tested for pH, osmolality, endotoxin, sterility, and sperm toxicity before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.
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    K Number
    K241132
    Device Name
    ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
    Manufacturer
    ARTSMedia Denmark ApS
    Date Cleared
    2024-12-18

    (238 days)

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

    ARTSMedia Denmark ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARTSMedia Oocyte Aspiration Medium (AM-Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes.
    Device Description
    ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes. ARTSMedia Oocyte Aspiration Medium consists of physiological salts, energy substrates, buffering agents, Human Serum Albumin, Gentamicin Sulphate, and water. Furthermore, ARTSMedia Oocyte Aspiration Medium is aseptically filtered and provided in a volume of 20 mL, 50 mL, and 100 mL in pre-sterilized glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The ARTSMedia Oocyte Aspiration Medium is tested for pH, osmolality, embryotoxicity, endotoxin, and sterility, before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.
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    K Number
    K220715
    Device Name
    ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
    Manufacturer
    ARTSMedia Denmark ApS
    Date Cleared
    2023-02-10

    (336 days)

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

    ARTSMedia Denmark ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer.
    Device Description
    ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a medium for in vitro fertilization and culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer procedures. The medium is aseptically filtered and provided in in a volume of 10 mL in pre-sterilized 10 mL glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The medium has a shelflife of 10 months when stored at 2-8℃ and is for single-use only.
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