BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Persona Medical

    DI: 00851362008070 · Model: Evok 1600 Wireless · Persona Medical
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Persona Medical
    Primary DI
    00851362008070
    Version / Model
    Evok 1600 Wireless
    Company Name
    Persona Medical
    Labeler DUNS
    101877157
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-01
    Public Version
    2
    Public Version Date
    2020-10-06
    Public Version Status
    Update
    Public Device Record Key
    d4b1f77d-c28f-4e25-8ff4-8aaae79aebc4

    Device Description

    Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OSM Hearing Aid, Air Conduction With Wireless Technology

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00851362008070