Duns Number:966390890
Device Description: FreeStyle Precision H Blood Glucose Test Strips
Catalog Number
80116
Brand Name
FreeStyle Precision H
Version/Model Number
80116
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
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
K070984,K070984,K070984
Product Code
LFR
Product Code Name
Glucose dehydrogenase, glucose
Public Device Record Key
3d5f21cc-6a47-4206-b0a7-59716087245f
Public Version Date
December 11, 2019
Public Version Number
5
DI Record Publish Date
July 22, 2016
Package DI Number
30093815801161
Quantity per Package
6
Contains DI Package
00093815801160
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 |