Flex Cardio Patient Monitoring System

  • Model / Serial
    Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KY, LA, MA, MI, MO, NC, NE, NM, NY, OH, OR, OK, PA, SD, TN, TX, VA, WA, WV and Internationally to Germany, Hungary, India, Netherlands, Russia, Saudi Arabia, South Africa and Tunisia.
  • Product Description
    Xper Flex Cardio PhysioMonitoring system || The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

14 devices with a similar name

Learn more about the data here

  • Model / Serial
    All Flex Cardio devices, Revision C Model/Product Numbers: 453564634201, 453564534211, 453564621791, 453564621801, 860335 and 860338 Flex Cardio devices, Revisions A and B To assist in identifying affected devices, each affected device has at least one of the following numbers on the label on its back: Service #: 453564241901 and 453564483321
  • Product Description
    Monitoring Systems, Physiologic
  • Manufacturer
  • Model / Serial
  • Product Description
    Medical electronics / Electromedical devices - electrodiagnostics
  • Manufacturer
  • Model / Serial
  • Product Description
    Philips Xper Flex Cardio Patient Monitoring System , INVIVO, a division of Philips Medical Systems
  • Manufacturer
  • Model / Serial
  • Product Description
    Philips: Flex Cardio patient monitoring system
  • Manufacturer
  • Model / Serial
  • Product Description
    Invivo: Flex Cardio Patient Monitoring System
  • Manufacturer
9 more