BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    JETi Saline Drive Unit

    DI: B139WV034510 · Model: WV0345-1 · WALK VASCULAR L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    JETi Saline Drive Unit
    Primary DI
    B139WV034510
    Version / Model
    WV0345-1
    Company Name
    WALK VASCULAR L.L.C.
    Labeler DUNS
    034774488
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-17
    Public Version
    4
    Public Version Date
    2022-09-27
    Public Version Status
    Update
    Public Device Record Key
    54e0077d-fe4a-44f7-85a0-f70db3c577ea
    Distribution End Date
    2021-06-03

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QEZ Aspiration Thrombectomy Catheter

    GMDN Terms

    Code Name
    58214 Mechanical atherectomy/thrombectomy drive system

    Identifiers

    Type ID
    Package B139WV034511
    Primary B139WV034510