Duns Number:080028910
Device Description: Mixed product shipper case containing 3 CONTOUR® NEXT ONE Blood Glucose Monitoring System Mixed product shipper case containing 3 CONTOUR® NEXT ONE Blood Glucose Monitoring System kits (Primary DI Number 00301939763012), 3 CONTOUR® NEXT EZ Blood Glucose Monitoring System kits (Primary DI Number 00301939628014) and 12 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Primary DI Number 10301937308502).
Catalog Number
9647
Brand Name
CONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR® NEXT
Version/Model Number
9647
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111268,K121190,K130265,K160430,K160682,K162336
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
e7263558-ad0a-45b4-8bbe-814cc1616b33
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 17, 2017
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 |