Duns Number:537208717
Device Description: The RVS-100 vital signs monitor is intended to be used for monitoring, displaying, reviewi The RVS-100 vital signs monitor is intended to be used for monitoring, displaying, reviewing, storing and sending alarms regarding multiple physiological patient parameters, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (Temp).
Catalog Number
1960-RRBXG
Brand Name
RVS-100,NIBP(Riester)+SpO2(Riester) + Pred. Temp
Version/Model Number
1960-RRBXG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K170538
Product Code
MWI
Product Code Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Public Device Record Key
cc76b9e1-cf89-4b26-b9b3-1bda1ab0c5fd
Public Version Date
February 05, 2021
Public Version Number
1
DI Record Publish Date
January 28, 2021
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 | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |