Duns Number:966390890
Device Description: FreeStyle Libre Sensor Kit
Catalog Number
71536
Brand Name
FreeStyle Libre
Version/Model Number
71536
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 03, 2020
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
P160030,P160030
Product Code
PZE
Product Code Name
Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Public Device Record Key
93f04e28-de0d-4be6-b190-cb59f9b53d0b
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
November 20, 2017
Package DI Number
30357599000197
Quantity per Package
24
Contains DI Package
00357599000196
Package Discontinue Date
December 03, 2020
Package Status
Not 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 |