Duns Number:966390890
Device Description: FreeStyle Libre 2 App iOS US
Catalog Number
71926-01
Brand Name
FreeStyle Libre 2 App
Version/Model Number
71926-01
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
K201761
Product Code
NBW
Product Code Name
System, test, blood glucose, over the counter
Public Device Record Key
2284d9c2-853b-4992-8001-3ad6a8facb6c
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 26, 2021
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 |