Duns Number:966390890
Device Description: FreeStyle CoPilot Health Management System
Catalog Number
71137
Brand Name
FreeStyle CoPilot
Version/Model Number
71137
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062770,K062770
Product Code
NBW
Product Code Name
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Public Device Record Key
32c525be-2f0c-438a-8e34-33b7c067e18a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 26, 2016
Package DI Number
30357599000173
Quantity per Package
30
Contains DI Package
00357599000172
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |
| 3 | A medical device with high risk that requires premarket approval | 2 |