BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    1byone

    DI: 00858069007085 · Model: PL-029K16B-P3 · 1BYONEPRODUCTS INC.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    1byone
    Primary DI
    00858069007085
    Version / Model
    PL-029K16B-P3
    Company Name
    1BYONEPRODUCTS INC.
    Labeler DUNS
    845019202
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-14
    Public Version
    2
    Public Version Date
    2020-06-05
    Public Version Status
    Update
    Public Device Record Key
    4a61522a-bee0-4c66-b460-cfe19de295ac

    Device Description

    Two different size pads, one is 4*4 cm pad ( 4 pieces) one is big pad. ( 1 pieces)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    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
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning
    IRT Pad, Heating, Powered
    NYN Stimulator, Electrical, Transcutaneous, For Arthritis
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

    GMDN Terms

    Code Name
    35372 Analgesic transcutaneous electrical nerve stimulation system

    Identifiers

    Type ID
    Primary 00858069007085
    Package 00858069007115
    Package 10858069007112