Duns Number:080028910
Device Description: Mixed product shipper case containing 3 cartons of CONTOUR® NEXT Blood Glucose Test Strips Mixed product shipper case containing 3 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Package DI Number 00301937312212) and 300 MICROLET® colored lancets (provided sterile).
Catalog Number
7771
Brand Name
CONTOUR® NEXT and MICROLET®
Version/Model Number
7771
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 27, 2020
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
4848c545-0949-4c38-9d94-5ed10ebb2199
Public Version Date
August 02, 2021
Public Version Number
2
DI Record Publish Date
November 21, 2019
Package DI Number
50301937771519
Quantity per Package
8
Contains DI Package
40301937771512
Package Discontinue Date
May 27, 2020
Package Status
Not 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 |