BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    U By Kotex

    DI: 10036000515784 · Model: Tampon · KIMBERLY-CLARK GLOBAL SALES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    U By Kotex
    Primary DI
    10036000515784
    Version / Model
    Tampon
    Company Name
    KIMBERLY-CLARK GLOBAL SALES, INC.
    Labeler DUNS
    829568273
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-23
    Public Version
    2
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    dba5cf4f-cc0e-4245-8dc2-47ad798b922f

    Device Description

    U BY KOTEX PREMIUM SECURITY TAMPON REGULAR/SUPER MULTIPACK 45

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    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
    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
    HEB Tampon, menstrual, unscented

    GMDN Terms

    Code Name
    35694 Menstrual tampon, unscented

    Identifiers

    Type ID
    Primary 10036000515784

    Customer Contacts

    Phone
    +1(800)335-6839
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K141294 000

    Device Sizes

    Type Value Unit Text
    Weight 12 Gram
    Weight 9 Gram