Duns Number:080028910
Device Description: Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (7 Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).
Catalog Number
7278
Brand Name
CONTOUR® NEXT
Version/Model Number
7278
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,K160430,K162336,P150001,P160017,K121190,K160430,K162336,P150001,P160017,P160017,P150001,K162336,K160430,K121190
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
10a8c694-48db-4d58-b837-910520d11ed4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 03, 2017
Package DI Number
40301937278707
Quantity per Package
12
Contains DI Package
00301937278709
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 |