Duns Number:534096359
Device Description: Endobronchial blocker.
Catalog Number
EBB09700
Brand Name
VivaSight-EB
Version/Model Number
EBB09700
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,K120334
Product Code
CBI
Product Code Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Public Device Record Key
db715a41-f976-48f0-a65d-81434a966895
Public Version Date
August 15, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
17290013745511
Quantity per Package
5
Contains DI Package
07290013745514
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 |