BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioKnit Conductive Garment

    DI: 00857771003552 · Model: KB0961 univ. cervical · BIOMEDICAL LIFE SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioKnit Conductive Garment
    Primary DI
    00857771003552
    Version / Model
    KB0961 univ. cervical
    Catalog Number
    KB0961
    Company Name
    BIOMEDICAL LIFE SYSTEMS, INC.
    Labeler DUNS
    116956807
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    5
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    40c947e1-45ce-46a4-925b-5b2ec47ea324

    Device Description

    qty 2 ea/pk with 2 x 3 electrodes

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GXY Electrode, Cutaneous

    GMDN Terms

    Code Name
    35995 Transcutaneous electrical stimulation electrode, single-use

    Identifiers

    Type ID
    Primary 00857771003552

    Customer Contacts

    Phone
    7607275600
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K053214 000

    Device Sizes

    Type Value Unit Text
    Height 8 Inch
    Length 11 Inch
    Width 1 Inch