BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Medical Imaging Solutions Intl.

    DI: 00850014500375 · Model: 200113 · MEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Medical Imaging Solutions Intl.
    Primary DI
    00850014500375
    Version / Model
    200113
    Company Name
    MEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANY
    Labeler DUNS
    005179271
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-15
    Public Version
    1
    Public Version Date
    2021-01-25
    Public Version Status
    New
    Public Device Record Key
    b9b142bd-f238-4903-803e-2399b09aa57a

    Device Description

    2-125ml syringes, 1 Y coiled connecting tubing with dual back check valves, 2 spikes YM

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    DXT Injector And Syringe, Angiographic

    GMDN Terms

    Code Name
    15286 Angiographic syringe

    Identifiers

    Type ID
    Package 10850014500372
    Primary 00850014500375

    Premarket Submissions

    Submission Number Supplement Number
    K152906 000