Duns Number:070156955
Catalog Number
1280N
Brand Name
THORATEC® HEARTMATE® XVE AND HEARTMATE II®, DISPLAY MODULE
Version/Model Number
1280N
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
-
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
DSQ
Product Code Name
Ventricular (Assisst) Bypass
Public Device Record Key
2b2d320e-f0a7-4d05-bdb4-5ea6fb7c763f
Public Version Date
October 24, 2022
Public Version Number
6
DI Record Publish Date
September 20, 2014
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 |