Duns Number:966390890
Device Description: FreeStyle InsuLinx Blood Glucose Monitoring System
Catalog Number
71500
Brand Name
FreeStyle InsuLinx
Version/Model Number
71500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 02, 2020
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152328,K152328
Product Code
LFR
Product Code Name
Glucose dehydrogenase, glucose
Public Device Record Key
a20ecc54-e8e2-4383-8e95-71ca9be4db67
Public Version Date
January 18, 2021
Public Version Number
4
DI Record Publish Date
August 12, 2016
Package DI Number
30093815715000
Quantity per Package
4
Contains DI Package
00093815715009
Package Discontinue Date
May 02, 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 |