Duns Number:874148340
Device Description: The Vios Monitoring System (VMS) Central Server (CS) Software acts as the server relay for The Vios Monitoring System (VMS) Central Server (CS) Software acts as the server relay for the VMS system. It transmits, stores, and encrypts patient demographic and vitals data between multiple Vios BSMs to the Vios CSM. The Vios Central Server allows for retrieval of patient demographics, vitals and alarm data and product utilization through retrieval of audit logs. The Vios Central Server 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.The Vios Central Station Monitor/Central Server Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios Central Station Monitor/Central Server SW receives, stores, manages and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.
Catalog Number
VCS2050
Brand Name
Vios Monitoring System Central Server
Version/Model Number
VCS2050 Software
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173107
Product Code
DXJ
Product Code Name
Display, Cathode-Ray Tube, Medical
Public Device Record Key
fe3b361e-45b9-4358-b701-152095f410db
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |