BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    S5 IMAGING SYSTEM P/N 807300001

    DI: 00845225010195 · Model: 807300001 · VOLCANO CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    S5 IMAGING SYSTEM P/N 807300001
    Primary DI
    00845225010195
    Version / Model
    807300001
    Company Name
    VOLCANO CORPORATION
    Labeler DUNS
    135179237
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-22
    Public Version
    4
    Public Version Date
    2021-10-26
    Public Version Status
    Update
    Public Device Record Key
    85798a25-c624-4a65-a22e-832c61c021a0

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OBJ Catheter, Ultrasound, Intravascular
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    GMDN Terms

    Code Name
    40763 Cardiovascular ultrasound imaging system

    Identifiers

    Type ID
    Primary 00845225010195

    Premarket Submissions

    Submission Number Supplement Number
    K071554 000