BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Welch Allyn

    DI: 04719872711162 · Model: 1008 · MEDIMAGING INTEGRATED SOLUTION INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Welch Allyn
    Primary DI
    04719872711162
    Version / Model
    1008
    Company Name
    MEDIMAGING INTEGRATED SOLUTION INC.
    Labeler DUNS
    656813438
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-01
    Public Version
    1
    Public Version Date
    2020-03-09
    Public Version Status
    New
    Public Device Record Key
    6824ee90-c320-47d2-a2fc-2af55250c6ff

    Device Description

    Eye Fundus Camera: RetinaVue 700 Imager (RV700-B)

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PJZ Camera, Ophthalmic, General-Use

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 04719872711162