BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACIST HDi® HD IVUS System

    DI: 40841716102101 · Model: 016375 · ACIST MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ACIST HDi® HD IVUS System
    Primary DI
    40841716102101
    Version / Model
    016375
    Company Name
    ACIST MEDICAL SYSTEMS, INC.
    Labeler DUNS
    926684994
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-30
    Public Version
    1
    Public Version Date
    2018-12-31
    Public Version Status
    New
    Public Device Record Key
    8f59821b-4b98-4c9d-a40e-d86025e01c64

    Device Description

    ACI Hardware, HDi System p/n 801085-001 Contents: ACI Hardware

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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

    GMDN Terms

    Code Name
    40763 Cardiovascular ultrasound imaging system

    Identifiers

    Type ID
    Primary 40841716102101