Duns Number:534096359
Device Description: A kit wich contains one sterile packed VivaSight SL (Oral/Nasal Cuffed visualization Endot A kit wich contains one sterile packed VivaSight SL (Oral/Nasal Cuffed visualization Endotracheal tube)and one Sterile packed VivaSight EB (Endobronchial blocker).
Catalog Number
TVEB70100
Brand Name
VivaSight Pack
Version/Model Number
TVEB70100
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
K120334,K152438,K120334,K152438
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
44547b92-debf-4e72-8dbd-16ee5e2625c6
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
17290013745542
Quantity per Package
5
Contains DI Package
07290013745545
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |