BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Measure by Otometrics - HIT

    DI: 05711781004297 · Model: HIT Pro Package · Auditdata A/S
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Measure by Otometrics - HIT
    Primary DI
    05711781004297
    Version / Model
    HIT Pro Package
    Catalog Number
    100.450
    Company Name
    Auditdata A/S
    Labeler DUNS
    310385849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-14
    Public Version
    1
    Public Version Date
    2025-11-24
    Public Version Status
    New
    Public Device Record Key
    9232d4a0-0c66-49c1-871c-ebca4d6beb7c

    Device Description

    2000 Primus HIT Pro

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

    GMDN Terms

    Code Name
    41217 Hearing aid tester, electrical

    Identifiers

    Type ID
    Primary 05711781004297