Duns Number:080028910
Device Description: Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood gluc Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose.This kit contains the following items: CONTOUR® Blood Glucose Meter; User Guide; Quick Reference Guide; Lancing Device; 10 colored lancets (provided sterile); Log Book; Carrying Case; Warranty Card
Catalog Number
7151H
Brand Name
CONTOUR®
Version/Model Number
7151H
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 20, 2017
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
K062058,K062058
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
b5ba61a4-ebc6-46af-acfe-61f5ec7bab0a
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
40301937151017
Quantity per Package
4
Contains DI Package
00301937151019
Package Discontinue Date
October 20, 2017
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 |