BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE Medical Systems Information Technologies, Inc.

    Reg #: 3012359877 · FEI: 3012359877 · Expires 2026
    View on FDA
    Products
    40
    Proprietary Names
    174
    Establishment Types
    2
    Classifications
    40

    Registration Details

    Registration Name
    GE Medical Systems Information Technologies, Inc.
    Registration Number
    3012359877
    FEI Number
    3012359877
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9900 Innovation Drive
    City
    Wauwatosa
    State
    WI
    ZIP
    53226
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133622

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Computer, Diagnostic, Programmable DQK
    Electrocardiograph DPS
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Recorder, Paper Chart DSF
    Blood Pressure Cuff DXQ
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Oximeter DQA
    System, Network And Communication, Physiological Monitors MSX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Monitor, Breathing Frequency BZQ
    Cable, Electrode IKD
    Alarm, Blood-Pressure DSJ
    Oximeter, Ear DPZ
    Reduced- Montage Standard Electroencephalograph OMC
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Probe, Thermodilution KRB
    Burst Suppression Detection Software For Electroencephalograph ORT
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Full-Montage Standard Electroencephalograph GWQ
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Continuous Measurement Thermometer FLL
    Computer, Blood-Pressure DSK
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Detector And Alarm, Arrhythmia DSI
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Monitor, St Segment With Alarm MLD
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Stimulator, Nerve, Peripheral, Electric KOI
    Display, Cathode-Ray Tube, Medical DXJ
    System, Monitoring, Perinatal HGM
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Cerebral Oximeter QEM
    Oximeter, Tissue Saturation MUD

    Proprietary Names

    MAC 2000 12SL ECG Analysis Program B1X5-REC, Recorder Radial-Cuf Non-invasive Blood Pressure Cuff Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait™ Central Viewer Application (Portrait CVA01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01) Portrait™ Sensor Battery (Portrait SBT01) Portrait™ Core Services (Portrait CSS01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01) Portrait™ Bedside Charger (Portrait BCH01) Portrait™ Mobile Patient Monitor (Portrait HUB01) Portrait™ Clinical Alarming Unit (Portrait CAU01) Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01) Portrait™ RR Electrode Patch (Portrait RRP01) Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01) DURA-CUF CLASSIC-CUF SENSA-CUF SOFT-CUF NIBP Hoses NIBP connectors NIBP adaptors (Dinaclick, Bayonet, Neo-Snap) ECG Trunk Cables and Leadwires Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables) ECG Adapter Cable NOVII INTERFACE CABLE - GE FECG MECG Cable FECG Cable CLAB ECG Trunk Cable 12-lead AHA 10ft CLAB ECG Trunk Cable 12-lead IEC 10ft NOVII INTERFACE CABLE - GE MECG Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA) 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in. NOVII INTERFACE CABLE - GE UA 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC long, 3.6 m Cable assembly ECG 3 lead neo AHA short, 1.8 m Cable assembly ECG 3 lead neo AHA long, 3.6 m 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC short, 1.8 m 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in. 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in. B1X5-F2, Second Frame B125M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M Monitor B155M B125P Patient Monitor Monitor B125P B105M Patient Monitor Monitor B105P B155M Patient Monitor APEXPRO RECEIVER SUBSYSTEM CARESCAPE TELEMETRY SYSTEM APEXPRO CH NONIN XPOD OXIMETER APEXPRO QUAD RECEIVER MODULE ApexPro Telemetry System CARESCAPE Telemetry Server CARESCAPE T4 Transmitter ApexPro CH Transmitter CARESCAPE Telemetry T4 Transmitter CARESCAPE T14 Transmitter ApexPro FH Transceiver ApexPro 400 MHz Receiver ApexPro 600 MHz Receiver CARESCAPE Telemetry Server V4 CARESCAPE TELEMETRY SERVER V4 UPGRADE EK12 V2 MLCL Upgrade BT21 SpecialsLab v6.9.6 R3 ComboLab v6.9.6 R3 CardioLab v7 ComboLab v7 CardioLab v6.9.6 R3 Mac-Lab v7 Mac-Lab v6.9.6 R3 CARESCAPE ONE CARESCAPE ECG CARESCAPE TEMP CARESCAPE PRES CARESCAPE SPO2 CARESCAPE DOCK FO CARDIOSOFT WEB CardioSoft V6.71. Cardiac Testing System CS V6.71 Cardiac Testing System CARDIOSOFT RESTING ECG CS V6.6. Cardiac Testing System CASE CASE V6.6. Cardiac Testing System CARDIOSOFT EKG VIEWER CASE V6.71. Cardiac Testing System CARDIOSOFT CLIENT Cardiosoft V6.72 CASE V6.7 CS V6.71 CARDIOSOFT EXERCISE STRESS TEST CardioSoft V6.73 CS V6.6 Cardiac Testing System CARDIOSOFT SERVER CardioSoft V6.71 Cardiac Testing System CASE V6.6 Cardiac Testing System CASE V6.71 Cardiac Testing System CASE V6.73 eMUSE Cardiology Information System MUSE Cardiology Information System MUSE Cardiology Information System V9 MUSE MUSE v9 MUSE NX HEART-Exercise VSP 4 Upgrade Software Portrait Core Services CSSXB Portrait RR P-RR01 Portrait BCH01 Portrait MMP01 Portrait AAB01 Portrait SpO2 P-W01 Portrait SpO2 P-SP01 Portrait SBT01 Portrait SpO2 P-SE01 Portrait SpO2 P-SA01 Portrait RRP01 Portrait CVAXB Portrait HUBXB Portrait HSWXB Portrait CAU01 CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System CSCS CSCS v2 CARESCAPE Central Station CARESCAPE Central Station v2 CARESCAPE Central Station v3 CSCS v3 MAC 3500 MAC 5500 HD MAC 5500 HD ECG ANALYSIS SYSTEM CAM HD CAM 14 CareIntellect Perinatal Mural Perinatal Surveillance MAC 600 Resting ECG Analysis System MAC 600 MAC 5 A4 MAC 5 A4 Resting ECG Analysis System MAC 5 A5 MAC 5 Lite Resting ECG Analysis System MAC 5 Lite MAC 5 A5 Resting ECG Analysis System MAC VU360 Resting ECG Analysis System CAM Connect 14, CC14 CAM Connect 14 with Barcode, CC14 w/BC CAM Connect 14 w/ BC 12 RL Algorithm Portrait VSM Vital Signs Monitor Portrait VSM Portrait™ VSM MLCL Client SW AltiX CardioLab AltiX ComboLab AltiX Mac-Lab AltiX MAC 7 - Resting ECG Analysis System MAC 7 Resting ECG Analysis System Solar 8000i Transport Pro with Patient Data Mo Patient Data Module Defib Sync Cables

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility