BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RCA

    DI: 06976120600045 · Model: RSH05BG · Huizhou Gold Rose Technology Co.,Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RCA
    Primary DI
    06976120600045
    Version / Model
    RSH05BG
    Company Name
    Huizhou Gold Rose Technology Co.,Ltd
    Labeler DUNS
    697778092
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-05
    Public Version
    1
    Public Version Date
    2023-07-13
    Public Version Status
    New
    Public Device Record Key
    2b3e03d6-66f5-47ad-a58e-e57fda7c1630

    Device Description

    Air-conduction hearing aid, behind-the-ear

    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
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QUF Hearing Aid, Air-Conduction, Over The Counter

    GMDN Terms

    Code Name
    34671 Air-conduction hearing aid, behind-the-ear

    Identifiers

    Type ID
    Primary 06976120600045