BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    EllaCup

    DI: 00868609000216 · Model: 1 · MIEUX LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EllaCup
    Primary DI
    00868609000216
    Version / Model
    1
    Company Name
    MIEUX LLC
    Labeler DUNS
    044916599
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-04
    Public Version
    4
    Public Version Date
    2020-07-07
    Public Version Status
    Update
    Public Device Record Key
    e6779632-0562-4d32-aefb-9b24967550b6
    Distribution End Date
    2017-12-31

    Device Description

    A cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.

    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
    No
    Has Manufacturing Date
    No
    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, non-latex, reusable

    Identifiers

    Type ID
    Primary 00868609000216