Duns Number:080028910
Device Description: Mixed product shipper case containing 1 carton of CONTOUR®NEXT Blood Glucose Test Strips ( Mixed product shipper case containing 1 carton of CONTOUR®NEXT Blood Glucose Test Strips (Package DI Number 00301937312212) and 100 MICROLET® lancets (provided sterile).
Catalog Number
9782
Brand Name
CONTOUR®NEXT and MICROLET®
Version/Model Number
9782
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
924462d8-a560-40aa-ac82-a5c41b27676c
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 30, 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 |