BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Welch Allyn, Inc.

    DI: 00732094223910 · Model: 901108 · WELCH ALLYN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Welch Allyn, Inc.
    Primary DI
    00732094223910
    Version / Model
    901108
    Catalog Number
    411215
    Company Name
    WELCH ALLYN, INC.
    Labeler DUNS
    198227881
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-24
    Public Version
    1
    Public Version Date
    2023-09-01
    Public Version Status
    New
    Public Device Record Key
    ff7f3f61-3283-4b3d-8fe3-a486aa4bceb2

    Device Description

    RETINAVUE NETWORK SOFTWARE VERSION 3.X

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NFJ System, image management, ophthalmic

    GMDN Terms

    Code Name
    58713 Retinal image analysis software

    Identifiers

    Type ID
    Primary 00732094223910

    Customer Contacts

    Phone
    +1(315)685-2834
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K181016 000