BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WavelyDx Ear Tip - Pack of 3

    DI: 00860007953736 · Model: 1480-03 · Wavely Diagnostics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    WavelyDx Ear Tip - Pack of 3
    Primary DI
    00860007953736
    Version / Model
    1480-03
    Catalog Number
    1480-03
    Company Name
    Wavely Diagnostics, Inc.
    Labeler DUNS
    116723050
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2026-04-03
    Public Version
    1
    Public Version Date
    2026-04-13
    Public Version Status
    New
    Public Device Record Key
    ed1faa7a-8a7e-400b-b09c-cac123943f93

    Device Description

    The WavelyDx Ear Tip is an accessory to the WavelyDx Middle Ear Fluid Scanner. The WavelyDx Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PTO Tester, Auditory Impedance, Exempt

    GMDN Terms

    Code Name
    36717 Impedance audiometer

    Identifiers

    Type ID
    Unit of Use 00860014810213
    Primary 00860007953736