Duns Number:080028910
Device Description: Mixed product shipper case containing 2 cartons of CONTOUR® NEXT Blood Glucose Test Strips Mixed product shipper case containing 2 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Package DI Number 00301937312212) and 200 MICROLET® lancets (provided sterile).
Catalog Number
9769
Brand Name
CONTOUR® NEXT and MICROLET®
Version/Model Number
9769
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
-
Product Code
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
3b818ecf-7b4b-4b69-ab69-3665c7101439
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
June 01, 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 |