BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Azurion

    DI: 00884838099210 · Model: Azurion 3 M15 · Philips Medical Systems Nederland B.V.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Azurion
    Primary DI
    00884838099210
    Version / Model
    Azurion 3 M15
    Catalog Number
    722222
    Company Name
    Philips Medical Systems Nederland B.V.
    Labeler DUNS
    413819707
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-26
    Public Version
    2
    Public Version Date
    2023-09-26
    Public Version Status
    Update
    Public Device Record Key
    18df31dd-6f89-404f-9742-12e91066fd9a

    Device Description

    Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat detector.

    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
    No
    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
    OWB Interventional Fluoroscopic X-Ray System
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    GMDN Terms

    Code Name
    37623 Stationary angiographic x-ray system, digital

    Identifiers

    Type ID
    Primary 00884838099210

    Premarket Submissions

    Submission Number Supplement Number
    K200917 000