BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Welch Allyn, Inc.

    DI: 00732094199420 · Model: 901031 · WELCH ALLYN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Welch Allyn, Inc.
    Primary DI
    00732094199420
    Version / Model
    901031
    Catalog Number
    39400-NP
    Company Name
    WELCH ALLYN, INC.
    Labeler DUNS
    198227881
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-17
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    02e389b1-51d4-451e-a538-2c2c16230dfd
    Distribution End Date
    2017-04-24

    Device Description

    Welch Allyn OAE Hearing Screener with Charging Stand, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit -- 3 mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100- 240 V, 50-60 Hz AC, Lithium-Ion Integrated Battery; IEC Plug Type-B, -C, -G, and -I

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EWO AUDIOMETER

    GMDN Terms

    Code Name
    41184 Tone audiometer, manual

    Identifiers

    Type ID
    Primary 00732094199420

    Customer Contacts

    Phone
    +1(315)685-2834
    Email
    [email protected]