Duns Number:080028910
Device Description: Kit contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit; MICROLET® NEXT Lancin Kit contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit; MICROLET® NEXT Lancing Device; 4 bags of MICROLET® lancets (25 per bag; provided sterile)
Catalog Number
9766
Brand Name
CONTOUR® NEXT ONE
Version/Model Number
9766
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 19, 2017
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
-
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
K160682
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
e62e4b23-3f3d-4efa-9208-468525358a65
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 17, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 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 |