Duns Number:080028910
Device Description: Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: C Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR® NEXT LINK Blood Glucose Meter; 25 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; MICROLET® 2 Lancing Device; Alternative Site Endcap; Adjustable Endcap; 25 Lancets (provided sterile); Quick Reference Guide; Wall Charger; User Guide; USB Extension Cable; Logbook; Carrying Case.
Catalog Number
9632
Brand Name
CONTOUR® NEXT LINK
Version/Model Number
9632
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
K110894,K122370,K160430,K110894,K122370,K160430
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
da1d6479-4be4-44b9-a3cf-3f4f0c1ad177
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
40301939632019
Quantity per Package
4
Contains DI Package
00301939632011
Package Discontinue Date
-
Package Status
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 |