AccessGUDID - DEVICE: Vios Monitoring System Central Server (B595VCS2050)

GUDID

Device Identifier (DI) Information

Brand Name: Vios Monitoring System Central Server
Version or Model: VCS2050 Software
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VCS2050
Company Name: MURATA VIOS, INC.

Primary DI Number: B595VCS2050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 026867345 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36870	Network server	A device designed to provide electronic data services within a computerized network (e.g., file services like collecting and storing data). It may be a part of a patient monitoring, nurse call, or home alert system.	Active	false
43239	Cardiac arrhythmia monitoring system	An assembly of devices comprised of modules or components (e.g., monitors, recorders, amplifiers) intended to be used to continually detect, measure, and display the electrical activity of the heart and to produce a visible or audible signal/alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical Device Data System
DXJ	Display, Cathode-Ray Tube, Medical
QYW	Hospital Cardiac Telemetry
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173107	000
K232354	000
K241728	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe3b361e-45b9-4358-b701-152095f410db
Public Version Date: March 24, 2025
Public Version Number: 5
DI Record Publish Date: May 01, 2020