BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    The DivaCup

    DI: 00050428645598 · Model: Model A PL · Diva International Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    The DivaCup
    Primary DI
    00050428645598
    Version / Model
    Model A PL
    Catalog Number
    722537
    Company Name
    Diva International Inc
    Labeler DUNS
    207651758
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-19
    Public Version
    2
    Public Version Date
    2025-07-14
    Public Version Status
    Update
    Public Device Record Key
    2bca88f5-da24-4ad8-88e2-37b1bcbd3b5f

    Device Description

    Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HHE Cup, Menstrual

    GMDN Terms

    Code Name
    47728 Menstrual cup/disc, non-latex, reusable

    Identifiers

    Type ID
    Primary 00050428645598