BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    pjur analyse me! water-based

    DI: 00827160112158 · Model: pjur analyse me! water-based 100 ml - USA · Pjur Group Luxembourg SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    pjur analyse me! water-based
    Primary DI
    00827160112158
    Version / Model
    pjur analyse me! water-based 100 ml - USA
    Catalog Number
    12820-02
    Company Name
    Pjur Group Luxembourg SA
    Labeler DUNS
    400744553
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-25
    Public Version
    6
    Public Version Date
    2022-08-31
    Public Version Status
    Update
    Public Device Record Key
    63824602-5f2d-4581-85e8-a01cce6d59a3

    Device Description

    Water-based Personal Lubricant with Hyaluron

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NUC Lubricant, Personal

    GMDN Terms

    Code Name
    60412 Sexual lubricant

    Identifiers

    Type ID
    Package 40827160112156
    Package 10827160112155
    Primary 00827160112158

    Premarket Submissions

    Submission Number Supplement Number
    K010199 000
    K200527 000