BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BodyMed

    DI: 00815802018821 · Model: ZZAEV820OTC · BOXOUT, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BodyMed
    Primary DI
    00815802018821
    Version / Model
    ZZAEV820OTC
    Catalog Number
    ZZAEV820OTC
    Company Name
    BOXOUT, LLC
    Labeler DUNS
    066689993
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-05
    Public Version
    8
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    a10c2a12-302f-479a-a78d-f4dc75ce33d0

    Device Description

    BODYMED DIGITAL OVER THE COUNTER TENS UNIT

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 00815802018821
    Package 20815802018825
    Package 10815802018828

    Customer Contacts

    Phone
    866-528-2152
    Email
    [email protected]