Duns Number:966390890
Device Description: FreeStyle Precision Neo Blood Glucose Test Strips Not For Retail Sale
Catalog Number
71748
Brand Name
FreeStyle Precision Neo
Version/Model Number
71748
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
K171941,K171941,K171941
Product Code
NBW
Product Code Name
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Public Device Record Key
15332bf8-19d6-4a37-84c6-29f17fb87a9c
Public Version Date
October 19, 2021
Public Version Number
3
DI Record Publish Date
April 13, 2018
Package DI Number
30357599000333
Quantity per Package
50
Contains DI Package
00357599000332
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 |