Duns Number:070156955
Device Description: System Controller Low Flow 2.0
Catalog Number
106531LF2
Brand Name
Thoratec® HeartMate 3™
Version/Model Number
106531LF2
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
P160054
Product Code
DSQ
Product Code Name
Ventricular (assist) bypass
Public Device Record Key
43e685c8-fc42-448f-9c4b-de5306bf8954
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
February 13, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 156 |