BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioButton Adhesive V2 (ADH-CS)

    DI: 00850005949541 · Model: ADH-CS-10771 · BIOINTELLISENSE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    7
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioButton Adhesive V2 (ADH-CS)
    Primary DI
    00850005949541
    Version / Model
    ADH-CS-10771
    Catalog Number
    N/A
    Company Name
    BIOINTELLISENSE, INC.
    Labeler DUNS
    116984478
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-01
    Public Version
    1
    Public Version Date
    2024-05-09
    Public Version Status
    New
    Public Device Record Key
    10538fee-8fe6-458e-9ac7-6119479517d7

    Device Description

    BioButton Cold Seal Adhesive V2 (ADH-CS)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    Yes
    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
    KGX Tape And Bandage, Adhesive

    GMDN Terms

    Code Name
    16866 Dressing-fixation skin adhesive tape, non-silicone

    Identifiers

    Type ID
    Package 00850005949534
    Primary 00850005949541
    Package 00850005949510
    Package 10850005949517
    Package 20850005949514
    Package 00850005949527
    Package 10850005949524