BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    JVC

    DI: 00046838505065 · Model: EH-Z2000-H · Novidan, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    JVC
    Primary DI
    00046838505065
    Version / Model
    EH-Z2000-H
    Company Name
    Novidan, Inc.
    Labeler DUNS
    117003805
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-07
    Public Version
    1
    Public Version Date
    2025-05-15
    Public Version Status
    New
    Public Device Record Key
    13d98b25-0c36-44cc-8f12-07413b2af903

    Device Description

    Self-Fit OTC Hearing Aid Pair, wireless, rechargeable, cool gray color

    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
    Yes
    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 00046838505065
    Package 10046838505062