Duns Number:080028910
Device Description: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of b Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.Kit contains: CONTOUR® NEXT ONE blood glucose meter; 10 CONTOUR® NEXT blood glucose test strips; Lancing Device; 10 Colored MICROLET® lancets (provided sterile); User Guide (including CONTOUR® DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT control solution. A clear endcap is available for Alternative Site Testing (AST). It may not be included in your meter kit. If you perform AST and need a clear endcap (for palm), contact Diabetes Care Customer Service.
Catalog Number
9767
Brand Name
CONTOUR® NEXT ONE
Version/Model Number
9767
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
-
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,K160682
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
e49d70d6-64e5-416a-b9fd-c8bf659c34a0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 17, 2017
Package DI Number
40301939767018
Quantity per Package
4
Contains DI Package
00301939767010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper/case
| 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 |