Duns Number:874148340
Device Description: The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software is indicated for u The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software 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.
Catalog Number
CSM2050
Brand Name
Vios Monitoring System Central Station Monitor
Version/Model Number
CSM2050 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
d78b8bc2-2c4b-4692-a36f-56ad2da2460a
Public Version Date
May 19, 2020
Public Version Number
2
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 |