Duns Number:080028910
Device Description: "For self-testing, monitoring, and management of blood glucose.Kit contains: CONTOUR® NEXT "For self-testing, monitoring, and management of blood glucose.Kit contains: CONTOUR® NEXT GEN blood glucose meter, 20 CONTOUR® NEXT blood glucose test strips, Lancing Device, 20 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card"
Catalog Number
90004850
Brand Name
CONTOUR® NEXT GEN
Version/Model Number
7383
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
K193407,K193407
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
2695e7a5-db05-4d95-b8b7-b4f2b07abcd4
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
Package DI Number
40301937383012
Quantity per Package
4
Contains DI Package
00301937383014
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 |