BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bernafon

    DI: 05714464125166 · Model: 264782 · Sbo Hearing A/S
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bernafon
    Primary DI
    05714464125166
    Version / Model
    264782
    Company Name
    Sbo Hearing A/S
    Labeler DUNS
    306018410
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-12
    Public Version
    1
    Public Version Date
    2023-05-22
    Public Version Status
    New
    Public Device Record Key
    2af29dc7-65a6-4dfb-a047-cc92af8801f7

    Device Description

    BERNAFON APP 1.1.0 IOS

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    Yes
    PM Exempt
    Yes
    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
    OSM Hearing Aid, Air-Conduction with Wireless Technology, Prescription
    KLW Masker, tinnitus

    GMDN Terms

    Code Name
    57885 Hearing aid/implant system remote control

    Identifiers

    Type ID
    Primary 05714464125166

    Customer Contacts

    Phone
    +4539177100
    Email
    [email protected]