Duns Number:080028910
Device Description: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of d Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabetes.This kit contains the following items: CONTOUR® Next Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case; CONTOUR® NEXT Control Solution; Warranty Card.
Catalog Number
9697
Brand Name
CONTOUR® NEXT
Version/Model Number
9697
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121190,K160430,K121190,K160430
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
23d2ecae-fbfd-4a0b-bb17-a5de41ff5af8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
40301939697018
Quantity per Package
4
Contains DI Package
00301939697010
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 |