Duns Number:106295384
Device Description: Cardiac Resynchronization Therapy Pacemaker
Catalog Number
-
Brand Name
VISIONIST™ CRT-P
Version/Model Number
U225
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
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
P030005,P030005,P030005,P030005,P030005,P030005,P030005,P030005,P030005
Product Code
NKE
Product Code Name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Public Device Record Key
63f86dd9-9c5b-4681-874a-a70d7d4c001c
Public Version Date
October 01, 2021
Public Version Number
8
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |