Duns Number:080028910
Device Description: Diabetes Management Software
Catalog Number
85498754
Brand Name
CONTOUR® DIABETES APP
Version/Model Number
3537
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
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
d9859855-d47a-4d66-ac38-373c7c5a2b37
Public Version Date
February 28, 2022
Public Version Number
1
DI Record Publish Date
February 18, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |