BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Intimina KegelSmart

    DI: 07350022278004 · Model: 8004 · Leloi AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Intimina KegelSmart
    Primary DI
    07350022278004
    Version / Model
    8004
    Company Name
    Leloi AB
    Labeler DUNS
    508701849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-26
    Public Version
    1
    Public Version Date
    2022-06-03
    Public Version Status
    New
    Public Device Record Key
    e5540a7a-722e-4177-b61e-703e1dd282ce

    Device Description

    A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIR Perineometer

    GMDN Terms

    Code Name
    32686 Perineometer

    Identifiers

    Type ID
    Primary 07350022278004