Duns Number:080028910
Device Description: Mixed product shipper case containing 1 CONTOUR® NEXT ONE Blood Glucose Monitoring System Mixed product shipper case containing 1 CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Number 00301937818011), 2 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Package DI Number 00301937312212) and 200 MICROLET® lancets (provided sterile).
Catalog Number
9768
Brand Name
CONTOUR® NEXT ONE, CONTOUR® NEXT and MICROLET®
Version/Model Number
9768
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
-
Product Code
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
50cd459d-823b-4b3a-a52e-a37812d0dfd2
Public Version Date
September 20, 2018
Public Version Number
2
DI Record Publish Date
May 25, 2018
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 |