BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    JO Agape Original 2oz/60ml

    DI: B362420080 · Model: 42008 · CC Wellness LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    JO Agape Original 2oz/60ml
    Primary DI
    B362420080
    Version / Model
    42008
    Company Name
    CC Wellness LLC
    Labeler DUNS
    067692292
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-21
    Public Version
    7
    Public Version Date
    2023-10-09
    Public Version Status
    Update
    Public Device Record Key
    98dc12b6-9935-4dc9-897f-b2ab1735a537

    Device Description

    Water-based Personal Lubricant

    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
    Primary B362420080
    Package B362420081

    Premarket Submissions

    Submission Number Supplement Number
    K171021 000