BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Persona Medical

    DI: 00851362008315 · Model: Ole Deep CIC Custom Hearing Aid · 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
    00851362008315
    Version / Model
    Ole Deep CIC Custom Hearing Aid
    Company Name
    Persona Medical
    Labeler DUNS
    101877157
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-06
    Public Version
    1
    Public Version Date
    2022-10-14
    Public Version Status
    New
    Public Device Record Key
    65fa4422-7788-44e9-ac28-494b8b7d8a11
    Distribution End Date
    2022-10-10

    Device Description

    This is a deep fitting In-The-canal (ITC) custom hearing aid. The device is used for mild to severe hearing loss; this is programmable to enable computerized adjustments for a patient's hearing loss and related factors.

    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
    ESD Hearing Aid, Air Conduction

    GMDN Terms

    Code Name
    34672 Air-conduction hearing aid, in-the-ear

    Identifiers

    Type ID
    Primary 00851362008315