BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 06951214400084 · Model: APS-BER · Chongqing Kanghuaruiming S&T Co., Ltd..
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    06951214400084
    Version / Model
    APS-BER
    Company Name
    Chongqing Kanghuaruiming S&T Co., Ltd..
    Labeler DUNS
    543066376
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-22
    Public Version
    1
    Public Version Date
    2018-04-23
    Public Version Status
    New
    Public Device Record Key
    f6d62d82-a19e-4ae6-aaaa-ad013c9fac9c

    Device Description

    This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein-Angiography camera and digital-fundus-images acquisition and processing system, which can continuously display real-time, high quality color fundus images as well as black-white Fundus-Fluorescein-Angiography video images. The fundus images acquisition and processing system can process (full digital), record (real-time and completely) and save the color fundus images as well as retinal-fluorescein-angiography dynamic & static images into the computer. You can modify pictures, check reports, edit Graph-texts and manage all the dates at any time you want; you can measure and calculate the size of the case focus; you can zoom, move, stick, and put together the pictures; you can adjust the color on the picture, you can also record all the data on the CD, which can assistant scientific research and teaching. This system has combine function of many fundus image acquisition instruments, which can support medical treatments.

    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
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HKI Camera, Ophthalmic, Ac-Powered

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 06951214400084