BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FineTuner Echo

    DI: 09008737344290 · Model: 34429 · Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FineTuner Echo
    Primary DI
    09008737344290
    Version / Model
    34429
    Company Name
    Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
    Labeler DUNS
    300764032
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-03
    Public Version
    1
    Public Version Date
    2022-10-11
    Public Version Status
    New
    Public Device Record Key
    de6b7f66-4fbc-402b-b064-aaf46d14ccdd

    Device Description

    Audio Processor Remote Control

    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
    MR Unsafe
    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
    MCM Implant, Cochlear

    GMDN Terms

    Code Name
    57885 Hearing aid/implant system remote control

    Identifiers

    Type ID
    Primary 09008737344290

    Customer Contacts

    Phone
    1-888-633-3524
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P000025 108

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -4 – 140 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    41 – 104 Degrees Fahrenheit
    Type
    Handling Environment Temperature
    Temperature Range
    5 – 40 Degrees Celsius
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    700 – 1013 millibar
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 93 Percent (%) Relative Humidity
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 93 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    700 – 1013 millibar