Duns Number:080028910
Device Description: Blood Glucose Test Strips - 10 Test Strips.
Catalog Number
7313
Brand Name
CONTOUR® NEXT
Version/Model Number
7313
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
Yes
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,K162336,P150001,P160017,K121190,P160017,P150001,K162336,P160017,K160430,K121190,P150001,K162336,K160430,K121190,K162336,P150001,P160017,K160430
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
046a287f-adfb-41f8-956a-7a448b73f143
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
August 25, 2016
Package DI Number
40301937313101
Quantity per Package
24
Contains DI Package
00301937313103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
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 |