Duns Number:966390890
Device Description: FreeStyle Precision Neo Blood Glucose Monitoring System Not For Retail Sale
Catalog Number
71741
Brand Name
FreeStyle Precision Neo
Version/Model Number
71741
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
K142928,K142928
Product Code
LFR
Product Code Name
Glucose dehydrogenase, glucose
Public Device Record Key
4a6e2b94-8c15-44c4-b8ac-3ca003e5482d
Public Version Date
October 19, 2021
Public Version Number
4
DI Record Publish Date
December 06, 2017
Package DI Number
30357599000302
Quantity per Package
4
Contains DI Package
00357599000301
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 |