murata.comVios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
Murata Vios, Inc.
Murata Vios, Private Limited
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015181391 | 3015181391 | Murata Vios, Private Limited | 1 | N | 2026-01-01 | Prestige Sterling Square No.204, 3rd Floor, Wing-A, 3, Madras Bank Road, Kodihalli, Bangalore Karnataka IN 560001 |
| 3015328411 | 3015328411 | Murata Vios, Inc. | 1 | N | 2026-01-01 | 700 Commerce Drive, Suite 190 Woodbury MN US 55125 |
| 3015180161 | 3015180161 | Murata Vios, Inc. | 1 | N | 2020-04-25 | Attention: Steve Baker 3079 Premiere Pkwy Ste 140 Duluth GA US 30097 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B595BSM20500 | Vios Monitoring System Bedside Monitor - The Vios Monitoring System (VMS) Bedside Monitor (BSM) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.The VMS BSM is intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. | 866-990-1434 | ViosSupport@murata.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 227664 | 1393882994 | K241728 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | DXN | 2025-01-23 |
| 227680 | 1393882994 | K241728 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | DXN | 2025-01-23 |
| 227664 | 1373523331 | K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | DRT | 2024-03-22 |
| 227680 | 1373523331 | K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | DRT | 2024-03-22 |
| 227663 | 1788223870 | K173107 | Vios Central Station Monitor Software, Vios Central Server Software | DXJ | 2018-07-26 |
| 227664 | 1788223870 | K173107 | Vios Central Station Monitor Software, Vios Central Server Software | DXJ | 2018-07-26 |
| 227680 | 1788223870 | K173107 | Vios Central Station Monitor Software, Vios Central Server Software | DXJ | 2018-07-26 |
| 227663 | 1868203503 | K172586 | Vios Monitoring System™ Model 2050 | DRT | 2018-06-22 |
| 227664 | 1868203503 | K172586 | Vios Monitoring System™ Model 2050 | DRT | 2018-06-22 |
| 227680 | 1868203503 | K172586 | Vios Monitoring System™ Model 2050 | DRT | 2018-06-22 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Vios Monitoring System Bedside Monitor - The Vios Monitoring System (VMS) Bedside Monitor (BSM) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.The VMS BSM is intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
2020-05-01
Vios Monitoring System Central Station Monitor - The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software (SW) is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios CSM SW receives, stores, manages, and displays patient physiological and waveform data, and alarms generated by Vios proprietary patient vitals monitoring software. The Vios CSM SW is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
2020-05-01
Vios Monitoring System Central Server - The Vios Monitoring System (VMS) Central Station Monitor (CSM)/Central Server (CS) Software (SW) is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM SW and CS SW receives, stores, manages and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.The VMS CS SW acts as the server relay for the VMS system. It transmits, stores, and encrypts patient demographic and vitals data between multiple Vios Bedside Monitors (BSMs) to the Vios CSM. The Vios CS SW allows for retrieval of patient demographics, vitals and alarm data and product utilization through retrieval of audit logs. The Vios CS SW allows for creation and configuration of Monitoring Units (i.e. Wards), Caregivers, Departments, Rooms, Beds, and Default Monitoring Profiles for BSMs that are in Connected Mode.
2020-05-01
Vios Monitoring System Mobile Application - The Vios Monitoring System (VMS) Mobile Application is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios Mobile Application receives and displays patient physiological and waveform data and alarms generated by Vios’ proprietary patient vitals monitoring software. The Vios Mobile Application is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
2020-05-01
Vios Monitoring System Pulse Oximetry Sensor - The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
2020-04-27
Vios Monitoring System Chest Sensor - The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
2020-04-02
Vios Montioring System Adapter - The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions. The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
2020-04-02