Duns Number:006261481
Device Description: MON 2020C2 CARELINK 60601 3ED USA
Catalog Number
-
Brand Name
MEDTRONIC CARELINK EXPRESS™
Version/Model Number
2020C2
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
P890003
Product Code
NVZ
Product Code Name
Pulse generator, permanent, implantable
Public Device Record Key
08e89014-a657-4735-9abc-11a96278a8da
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 23, 2016
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |