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510(k) Data Aggregation

    K Number
    K232579
    Device Name
    Twoplus Applicator
    Manufacturer
    Hannah Life Technologies Pte Ltd.
    Date Cleared
    2023-12-21

    (118 days)

    Product Code
    QYZ
    Regulation Number
    884.6110
    Why did this record match?
    Product Code :

    QYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The twoplus Applicator is indicated for over-the-counter home use by individuals who choose not to conceive through intercourse. The twoplus Applicator kit allows for semen collection and the vaginal canal. The twoplus Applicator should be used during the ovulatory phase of the menstrual cycle.
    Device Description
    Not Found
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    K Number
    K231645
    Device Name
    PherDal® At-Home Insemination Kit
    Manufacturer
    PherDal Fertility Science, Inc.
    Date Cleared
    2023-12-14

    (192 days)

    Product Code
    QYZ
    Regulation Number
    884.6110
    Why did this record match?
    Product Code :

    QYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PherDal® At-Home Insemination Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or have chosen not to conceive through intercourse, for semen collection and the delivery of semen to the vaginal canal. The PherDal® At-Home Insemination Kit should be used during the ovulatory phase of the menstrual cycle.
    Device Description
    The PherDal® At-Home Insemination Kit is a sterile, over-the-counter (OTC) medical device intended for intravaginal insemination (IVI) at home. It consists of three sets of sterile, single-use, plastic syringes and semen collection cups, and Instructions for Use. The collection cup is used to hold and contain the sperm and work in conjunction with the syringe when it is time to transfer the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally.
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    K Number
    K231203
    Device Name
    Mosie Baby Kit
    Manufacturer
    Mosie Baby
    Date Cleared
    2023-11-29

    (216 days)

    Product Code
    QYZ, OYZ
    Regulation Number
    884.6110
    Why did this record match?
    Product Code :

    QYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mosie Baby Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or choose not to conceive through intercourse, for semen collection and the delivery of semen or donor sperm to the vaginal canal. The Mosie Baby Kit should be used during the ovulatory phase of the menstrual cycle.
    Device Description
    The Mosie Baby Kit is an over-the-counter (OTC) device intended for intravaginal insemination (IVI) at home. The Mosie Baby Kit includes the following components: - Two Mosie syringes - Two Mosie collection cups - Instructions for Use. Each component is single-use only and supplied non-sterile. The collection cup is used to hold and contain the sperm and work in conjunction with the syringe when it is time to transfer the sperm into the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally. The syringe features a rounded front end with a slotted tip opening. The syringe has a rounded stopper that fits within the rounded end of the syringe to aid in sperm delivery from the syringe to the vagina. The syringe also contains flanges designed to aid in device handling during use.
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