Duns Number:526982680
Device Description: The Endobronchial tube contians 1Pc Fr31 Left Endobronchial tube,1Pc Multifunctional joint The Endobronchial tube contians 1Pc Fr31 Left Endobronchial tube,1Pc Multifunctional joint and 2Pcs Fr8 Suction catheter, 1Pc Fr10 Suction catheter.
Catalog Number
-
Brand Name
NA
Version/Model Number
Left:Fr31
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
K152251,K152251
Product Code
CBI
Product Code Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Public Device Record Key
ddbb6c71-b90f-48bd-b172-6aebceb48acb
Public Version Date
October 09, 2019
Public Version Number
1
DI Record Publish Date
October 01, 2019
Package DI Number
16938119326494
Quantity per Package
10
Contains DI Package
06938119326497
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |