Duns Number:534096359
Device Description: Visualized double lumen endobronchial tube set. The set includes DLVT35 tube +adapter cab Visualized double lumen endobronchial tube set. The set includes DLVT35 tube +adapter cable, two suction catheter 8RF and two mully suction catheter 10RF+Finger tip
Catalog Number
DLVT35LAS
Brand Name
VivaSight DL AS Set Includes
Version/Model Number
DLVT35LAS
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"
Yes
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
cfd4b216-9bdf-41b9-ac31-d922179efe2b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 21, 2018
Package DI Number
27290013745709
Quantity per Package
2
Contains DI Package
17290013745702
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 |