Duns Number:006261481
Device Description: SW M01A02 CARELINK SMARTSYNC IOS
Catalog Number
-
Brand Name
CareLink SmartSync™ Common Application
Version/Model Number
M01A02
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,K163008,P890003,P890003
Product Code
DTA
Product Code Name
TESTER, PACEMAKER ELECTRODE FUNCTION
Public Device Record Key
a2210463-7db5-46c8-a045-9041b8476918
Public Version Date
July 03, 2019
Public Version Number
6
DI Record Publish Date
May 25, 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 | 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 |