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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Children's Battery Pack green 27 cm

    DI: 09008737068530 · Model: 06853 · 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
    Children's Battery Pack green 27 cm
    Primary DI
    09008737068530
    Version / Model
    06853
    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
    2014-09-23
    Public Version
    6
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    a94bf484-c44c-4550-8142-53dc721296d9

    Device Description

    Audio Processor Battery Pack

    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
    No
    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
    58185 Cochlear implant/auditory brainstem implant battery

    Identifiers

    Type ID
    Primary 09008737068530

    Customer Contacts

    Phone
    +1(888)633-3524
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P000025 050
    P000025 051
    P000025 052
    P000025 059
    P000025 104

    Storage Conditions

    Type
    Handling Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    50 – 113 Degrees Fahrenheit
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 45 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -4 – 140 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    700 – 1060 millibar
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    700 – 1060 millibar