Duns Number:966390890
Device Description: FreeStyle Libre 3 iOS App US
Catalog Number
72077-01
Brand Name
FreeStyle Libre 3 App
Version/Model Number
72077-01
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
-
Product Code
QLG
Product Code Name
Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
Public Device Record Key
e9d52f99-5a76-459e-82a9-e8cee72f0f89
Public Version Date
July 13, 2022
Public Version Number
1
DI Record Publish Date
July 05, 2022
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 | 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 |