Duns Number:715919973
Device Description: UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right lung in thoracic surgery, lung resection, VATS, lobectomy, etc.
Catalog Number
1203104
Brand Name
UNIBLOCKER
Version/Model Number
5.0FR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K894337
Product Code
CBI
Product Code Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Public Device Record Key
8a525baa-f35b-4aac-b6ef-a2bba69f8cba
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |