BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TotalExam® Lite & Oto 2.0

    DI: 00850033167047 · Model: GMD5505HD20 · GLOBALMEDIA GROUP, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TotalExam® Lite & Oto 2.0
    Primary DI
    00850033167047
    Version / Model
    GMD5505HD20
    Catalog Number
    GMD5505HD20
    Company Name
    GLOBALMEDIA GROUP, LLC
    Labeler DUNS
    103201849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-04
    Public Version
    1
    Public Version Date
    2023-08-14
    Public Version Status
    New
    Public Device Record Key
    0262faf4-558b-41fc-afc5-33a19e1b7b31

    Device Description

    TotalExam® Lite & Oto 2.0 Camera Kit, Includes General Exam and Otoscope.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    KZF Device, Medical Examination, Ac Powered

    GMDN Terms

    Code Name
    58857 Multi-purpose digital medical camera

    Identifiers

    Type ID
    Primary 00850033167047

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius