Duns Number:874148340
Device Description: The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medicall 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, 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 Vios Chest Sensor and Adapter 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.
Catalog Number
CS2050
Brand Name
Vios Monitoring System Chest Sensor
Version/Model Number
CS2050 Chest Sensor
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172586,K172586
Product Code
DPZ
Product Code Name
Oximeter, Ear
Public Device Record Key
f634dc85-68a3-4493-9a46-307983fbc8df
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
April 02, 2020
Package DI Number
B595L2050G1
Quantity per Package
32
Contains DI Package
B595CS20500
Package Discontinue Date
July 22, 2020
Package Status
Not in Commercial Distribution
Package Type
case
| 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 |