BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioButton Rechargeable Adhesives (ADD-HT)

    DI: 00850005949244 · Model: ADH-AC1-BBR-5-1-1-10 · BIOINTELLISENSE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    8
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioButton Rechargeable Adhesives (ADD-HT)
    Primary DI
    00850005949244
    Version / Model
    ADH-AC1-BBR-5-1-1-10
    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
    2022-07-20
    Public Version
    2
    Public Version Date
    2023-11-30
    Public Version Status
    Update
    Public Device Record Key
    cde0eba4-a345-46e8-8da1-9bdd06282fd3

    Device Description

    Adhesive accessory packs for wearable devices - 5 pcs, ADD, HT; SKU: ADH-AC1-BBR-5-1-1-10

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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 10850005949241
    Primary 00850005949244
    Package 30850005949245
    Package 20850005949248
    Package 40850005949242
    Package 00850005949435
    Package 20850005949439
    Package 30850005949436