Duns Number:966390890
Device Description: FreeStyle Libre 3 Sensor Kit US
Catalog Number
72081
Brand Name
FreeStyle Libre 3
Version/Model Number
72081
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"
-
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
-
Product Code
QLG
Product Code Name
Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
Public Device Record Key
1fa33a83-fa48-4b21-970e-b00ebf414036
Public Version Date
July 01, 2022
Public Version Number
1
DI Record Publish Date
June 23, 2022
Package DI Number
30357599818006
Quantity per Package
1
Contains DI Package
00357599818005
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 |