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.This kit contains the following items: CONTOUR® Next EZ Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case.
Catalog Number
9628
Brand Name
CONTOUR® NEXT EZ
Version/Model Number
9628
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
K111268,K130265,K162336,K111268,K162336,K130265
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
40e2d11c-e161-4513-bdff-54bf7d96ef14
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
40301939628012
Quantity per Package
4
Contains DI Package
00301939628014
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 |