Duns Number:791048924
Device Description: TRIUMPH Aortic Occlusion Perfusion Cannula, 19 Fr
Catalog Number
-
Brand Name
Triumph Aortic Perfusion Cannula
Version/Model Number
MPH-0019S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 06, 2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
5f909792-098f-464d-8f89-42aa3d4c83a7
Public Version Date
August 05, 2022
Public Version Number
5
DI Record Publish Date
March 09, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |