Duns Number:080028910
Device Description: Welcome kit - contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Welcome kit - contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Number 00301939763012), 1 carton of CONTOUR® NEXT ONE Blood Glucose Test Strips (Package DI Number 00301937312212), 100 MICROLET® lancets (provided sterile), recipe cards, activity cards, resistance bands (labeled latex free), relaxation mask.
Catalog Number
7750
Brand Name
ABOUND®
Version/Model Number
7750
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"
Yes
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
71716812-717e-4394-b402-760179b7e698
Public Version Date
September 02, 2019
Public Version Number
2
DI Record Publish Date
June 06, 2019
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 |