BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LUMIN

    DI: 04719896530077 · Model: UMD3-21B01 · ACULA TECHNOLOGY CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    LUMIN
    Primary DI
    04719896530077
    Version / Model
    UMD3-21B01
    Company Name
    ACULA TECHNOLOGY CORPORATION
    Labeler DUNS
    656742004
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-29
    Public Version
    1
    Public Version Date
    2024-11-06
    Public Version Status
    New
    Public Device Record Key
    afb2235b-4aa9-453d-95e5-bc816ecbff3e

    Device Description

    21.3" 3MP Color LCD Medical Display

    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
    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
    PGY Display, Diagnostic Radiology

    GMDN Terms

    Code Name
    36612 Image display unit, colour

    Identifiers

    Type ID
    Primary 04719896530077
    Package 14719896530074

    Premarket Submissions

    Submission Number Supplement Number
    K233336 000