Duns Number:080028910
Device Description: Blood glucose test strips. Sold in a carton of 15 test strips.
Catalog Number
7550
Brand Name
CONTOUR®NEXT
Version/Model Number
7550
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P150001,P160017,K191286,K191286,P150001,P160017,K191286,P150001,P160017,P150001,P160017,K191286
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
c1943aef-2a71-4eb5-a589-890a2ab034de
Public Version Date
November 22, 2019
Public Version Number
2
DI Record Publish Date
August 30, 2019
Package DI Number
40301937550155
Quantity per Package
24
Contains DI Package
00301937550157
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 |