BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vital Control

    DI: 00853879007089 · Model: SEM44 (Art.-No.: 666.64) · BEURER NORTH AMERICA, L.P.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vital Control
    Primary DI
    00853879007089
    Version / Model
    SEM44 (Art.-No.: 666.64)
    Company Name
    BEURER NORTH AMERICA, L.P.
    Labeler DUNS
    078497467
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-29
    Public Version
    10
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    920791d9-7152-4a94-bda5-4f48bc7ac59a

    Device Description

    TENS / EMS Device

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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
    35995 Transcutaneous electrical stimulation electrode, single-use
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Package 10853879007086
    Primary 00853879007089

    Customer Contacts

    Phone
    1-800-536-0366
    Email
    [email protected]