Duns Number:966390890
Device Description: FreeStyle Libre 2 Flash Glucose Monitoring System Reader
Catalog Number
71953
Brand Name
FreeStyle Libre 2
Version/Model Number
71953
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
K193371,K193371
Product Code
NBW
Product Code Name
System, test, blood glucose, over the counter
Public Device Record Key
3d60802f-608a-4d4c-8729-da679a686d3a
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
July 31, 2020
Package DI Number
30357599803002
Quantity per Package
4
Contains DI Package
00357599803001
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 |