Duns Number:537208717
Device Description: The RVS-200 Wall Diagnostic Station and RVS-200 Extension Module were produced for use wit The RVS-200 Wall Diagnostic Station and RVS-200 Extension Module were produced for use with various instrument heads fornon-invasive diagnosis of ENT and Ophthalmology.
Catalog Number
1961-RNBXU
Brand Name
RVS-200, NIBP(Riester) +SpO2(Nellcor) + Pred. Temp
Version/Model Number
1961-RNBXU
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
-
Product Code
ERA
Product Code Name
Otoscope
Public Device Record Key
50f6d746-772e-4441-9c48-7c9a3fd3a732
Public Version Date
July 27, 2021
Public Version Number
1
DI Record Publish Date
July 19, 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 |