Duns Number:966390890
Device Description: FreeSyle Libre Software CD
Catalog Number
71527
Brand Name
FreeStyle Libre
Version/Model Number
71527
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
-
Product Code
PHV
Product Code Name
Continuous glucose monitor retrospective data analysis software
Public Device Record Key
7f8886dd-8c0f-49fe-9cf0-60feacd0ab2f
Public Version Date
May 18, 2021
Public Version Number
3
DI Record Publish Date
December 22, 2017
Package DI Number
30357599000470
Quantity per Package
8
Contains DI Package
00357599000479
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 |