BEUDAMED
    FDA Registration Active 🇺🇸 United States

    WorkMate™ Scribe™ Module, Software Upgrade Kit

    Reg #: 3005334138 · FEI: 3005334138 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    99
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    St. Jude Medical, Cardiology Division, Inc.
    Registration Number
    3005334138
    FEI Number
    3005334138
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5050 Nathan Lane North
    City
    Plymouth
    State
    MN
    ZIP
    55442
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210392

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    WorkMate™ Scribe™ Module, Software Upgrade Kit WorkMate Claris™ System, Display Plus Amplifier Cable Assy, IBP, Omedha DTXX Catheter Input Module 1-56 EP-WorkMate/EP-4 USB Keyboard WorkMate Scribe Module 110V with Physio Catheter Input Module 57-120 WM Claris Z440 v.1.2 Upgrade Kit Cable Assy, IBP, Namic Preceptors DT WorkMate Scribe Module WorkMate Claris OS Patch SW Kit WorkMate Unity DICOM Module Fiber Optic Cable - Duplex LC/LC Power Supply Connector Adapter LCD Dual Monitor Mount Kit Reverse IEC Accessory Power Strip Cable Assy, IBP, Baxter Truwave WorkMate ImageSync Module incorrect Power Cord, C-18 to C-7, 250V SCU II Assembly 448 Channel EP-4 Stimulator System 110V Cable Assy, IBP, Merit Meritrans WorkMate Unity HL7 Module SCU II Assembly 96 Channel Cable Assy, IBP, Medex 860 WM Scribe Onyx v.1.2 Upgrade Kit v.1.2.1 Onyx Scribe Upgrade Kit 4 Outlet Reverse IEC Accessory Power Str Cable Assy, IBP, Utah Deltran Cable Assy, IBP, Medex 950 Fiber Optic Cable - Duplex LC/LC 30m WM Claris Additional Monitor Cable Kit Monitor, Touch Screen LCD, 19 Inch Media Conv, SC Fiber to DB9 USB Keyboard, Wired, English Cable Assy, IBP, Abbott Transpac IV DVI to DisplayPort Adapter WorkMate Claris™ System, ECG Cable Set, Radiolucent EP-4 Cardiac Stimulator DMS59 to Dual DVI SPlitter Video Cable Cable, COAX v.1.2.1 Z620 Upgrade Kit WorkMate Claris Bed Rail Kit WorkMate Claris PM Kit DWG 90169898 WM Claris Z620 v.1.2 Upgrade Kit Ferrite, Round Cable Snap-its, 200MHz-10 Cable Equipotential Kit WM Claris V1.1 Upgrade WorkMate Claris™ System, Cable Kit WorkMate Claris™ System, ECG Cable Set, Radiopaque Radiotranslucent Leadwire WorkMate Claris™ System, Bed Rail Kit WorkMate Claris™ System, Bed Bracket Assembly WorkMate Scribe CPU WM Unity Review Mod - Sgl User License Cable, Serial, 3 ft DB9 Power Supply, 5V MG with 2.5MM I.D. USB Optical Scroll Mouse, Wired v.1.2.1 Z440 Upgrade Kit WM Unity Review Module - Site License Monitor, LCD, 16:9 1920x1080 Resolution WorkMate Claris™ System, Grounding Cable WorkMate Claris™ System, System - Display Plus WorkMate Claris™ System, ECG Cable DVI to HDMI Adapter EP-4 Touch Screen Computer Additional Monitor Stand Kit WM Unity Review Module - 10 User License Cable Assy, Stim, EP4 S-Video to VGA Signal Converter Power Conditioner, 120 VAC, 1440 VA Medi Cable Assy, IBP, Medex 960 Media Conv, DB9 to Fiber SC Ferrite round cable snap its 1 to 300MHz Stim Cable, WorkMate Claris Generic WM Claris Power Kit, 110 Power Conditioner, 120 VAC, 600 VA, Keyboard, PS2, Wired 2-port DVI splitter WorkMate™ Scribe™ Module, Display Workstation Kit ECG Cable Radio-Translucent 36in Brn Mouse, PS2, Wired WM Claris CPU Cable Assy, IBP, Maxxim Cobe WorkMate Claris™ System, Bottom Shelf Computer Bench WorkMate Claris™ System, CI Module 1 WorkMate Claris™ System, Invasive Blood Pressure Cable WorkMate Claris™ System, Software Upgrade Kit WorkMate Claris™ System, Generic Stimulator Cable WorkMate Claris™ System, Printer WorkMate Claris™ System, Preventative Maintenance Kit WorkMate Claris™ System, Bracket Bottom Shelf Computer Bench WorkMate Claris™ System Display Workstation EP-4™ Cardiac Stimulator, Cardiac Stimulator Cable WorkMate Claris™ System, CI Module 2 WorkMate Claris™ System WorkMate Claris™ System, Module Cart WorkMate Claris™ System, Cart WorkMate Claris™ System, Amplifier

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198