Duns Number:944642730
Device Description: VistaHub-WiFi relay device to be used with the Vista Solution and VitalPatch biosensor.
Catalog Number
8001-01
Brand Name
VistaHub-WiFi
Version/Model Number
8001-01
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152139
Product Code
DRG
Product Code Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Public Device Record Key
76fbca64-93b4-4c20-92f8-f66d169e2d3d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 20, 2018
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |