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 Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips (UDI-DI: 20301930000370); MICROLET® NEXT Lancing Device; 10 MICROLET® Lancets; User Guide; Quick Reference Guide; Carrying Case; CONTOUR® NEXT Control Solution.
Catalog Number
90007938
Brand Name
CONTOUR® NEXT ONE
Version/Model Number
9550
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
K210687,K210687
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
42fa641c-d09a-41de-ac8e-e4dadc2ef0e5
Public Version Date
December 16, 2021
Public Version Number
1
DI Record Publish Date
December 08, 2021
Package DI Number
40301939550016
Quantity per Package
4
Contains DI Package
00301939550018
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 |