BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BioMed 2000 XL

    DI: 00857771003149 · Model: 2000XL · BIOMEDICAL LIFE SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioMed 2000 XL
    Primary DI
    00857771003149
    Version / Model
    2000XL
    Catalog Number
    KBXL
    Company Name
    BIOMEDICAL LIFE SYSTEMS, INC.
    Labeler DUNS
    116956807
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    5
    Public Version Date
    2019-10-23
    Public Version Status
    Update
    Public Device Record Key
    62b0d279-7932-4f0d-a154-35a025fd4000
    Distribution End Date
    2017-01-04

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

    GMDN Terms

    Code Name
    35372 Analgesic transcutaneous electrical nerve stimulation system

    Identifiers

    Type ID
    Primary 00857771003149

    Customer Contacts

    Phone
    7607275600
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K061476 000

    Device Sizes

    Type Value Unit Text
    Width 2 Inch
    Depth 7 Inch
    Height 6 Inch