Duns Number:966390890
Device Description: FreeStyle Libre Pro Software
Catalog Number
75170
Brand Name
FreeStyle Libre Pro
Version/Model Number
75170
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
3f79de73-3fb9-415a-842c-5f4caf29c537
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 31, 2018
Package DI Number
30093815751701
Quantity per Package
30
Contains DI Package
00093815751700
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 |