Duns Number:313217003
Device Description: Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22
Catalog Number
-
Brand Name
Sensis Vibe Combo
Version/Model Number
11007642
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
DQK
Product Code Name
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Public Device Record Key
392a1813-589b-42a4-9b17-73d007565949
Public Version Date
November 17, 2021
Public Version Number
5
DI Record Publish Date
February 13, 2017
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. | 478 |
| 3 | A medical device with high risk that requires premarket approval | 1 |