BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    InfiMed Platinum One, DSA, CCD Camera

    DI: 00858086006108 · Model: PlatinumOne DSA · INFIMED, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    InfiMed Platinum One, DSA, CCD Camera
    Primary DI
    00858086006108
    Version / Model
    PlatinumOne DSA
    Company Name
    INFIMED, INC.
    Labeler DUNS
    197117211
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    3
    Public Version Date
    2019-12-09
    Public Version Status
    Update
    Public Device Record Key
    9f3fca8b-191f-4256-8ce6-09912e2d9032
    Distribution End Date
    2017-03-31

    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
    JAA System, x-ray, fluoroscopic, image-intensified
    OWB Interventional fluoroscopic x-ray system

    GMDN Terms

    Code Name
    40847 X-ray system computer, diagnostic, general-purpose

    Identifiers

    Type ID
    Primary 00858086006108