BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lexie Hearing

    DI: 00810153660811 · Model: Lexie B2 Powered by Bose (AARP Bundle) · HEARX GROUP (PTY) LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lexie Hearing
    Primary DI
    00810153660811
    Version / Model
    Lexie B2 Powered by Bose (AARP Bundle)
    Catalog Number
    LBS00001B2UF
    Company Name
    HEARX GROUP (PTY) LTD
    Labeler DUNS
    539177681
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-31
    Public Version
    1
    Public Version Date
    2025-08-08
    Public Version Status
    New
    Public Device Record Key
    68952711-dcf3-4f80-9c33-394f835aaae2

    Device Description

    Lexie B2 Powered by Bose (AARP)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter

    GMDN Terms

    Code Name
    47169 Air-conduction hearing aid, receiver-in-canal

    Identifiers

    Type ID
    Primary 00810153660811