BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Affiniti 50 Diamond Select Ultrasound System

    DI: 00884838106567 · Model: 795118 · Philips Ultrasound, Inc.
    View on AccessGUDID
    Product Codes
    6
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Affiniti 50 Diamond Select Ultrasound System
    Primary DI
    00884838106567
    Version / Model
    795118
    Company Name
    Philips Ultrasound, Inc.
    Labeler DUNS
    063377717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-21
    Public Version
    2
    Public Version Date
    2022-08-22
    Public Version Status
    Update
    Public Device Record Key
    7ea11b29-1e1d-4213-8cde-1f56b8ec7a9d

    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
    LLZ System, Image Processing, Radiological
    IYN System, Imaging, Pulsed Doppler, Ultrasonic
    IYO System, Imaging, Pulsed Echo, Ultrasonic
    ITX Transducer, Ultrasonic, Diagnostic
    OBJ Catheter, Ultrasound, Intravascular
    QIH Automated Radiological Image Processing Software

    GMDN Terms

    Code Name
    40761 General-purpose ultrasound imaging system

    Identifiers

    Type ID
    Primary 00884838106567