Duns Number:534096359
Device Description: Visualized double lumen endobronchial tube set. The set contains 1 DL tube, two pouches of Visualized double lumen endobronchial tube set. The set contains 1 DL tube, two pouches of suction catheter straight and two pouches of suction catheter curved.
Catalog Number
DLVT37
Brand Name
VivaSight-DL
Version/Model Number
DLVT37
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
K123853,K123853,K123853
Product Code
CBI
Product Code Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Public Device Record Key
8d8fe4e1-f8e6-4560-a098-f07708511c4b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
27290013745600
Quantity per Package
10
Contains DI Package
07290013745606
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 |