Duns Number:948683941
Device Description: TandemHeart blood pump kit with accessories (TRIS trial)
Catalog Number
-
Brand Name
TandemHeart-TRIS
Version/Model Number
5120-0000TRIS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 13, 2015
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
-
Product Code
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
5c4406a4-5212-495f-ab5f-339e3d96ba40
Public Version Date
May 19, 2020
Public Version Number
4
DI Record Publish Date
October 10, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |