Duns Number:534096359
Device Description: Oral/Nasal Cuffed visualization Endotracheal tube
Catalog Number
TVT75105
Brand Name
VivaSight-SL
Version/Model Number
TVT75105
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
Yes
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
K152438,K152438,K152438
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
1ba9769c-4767-4cad-8155-48bbc7318d0c
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
27290013745013
Quantity per Package
10
Contains DI Package
17290013745016
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 |