Duns Number:008171162
Device Description: The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measu The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes.
Catalog Number
-
Brand Name
GLUCOCARD® Shine Blood Glucose Monitoring System
Version/Model Number
540001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120351,K120351,K120351
Product Code
NBW
Product Code Name
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Public Device Record Key
903f15ec-8413-42c6-81fb-b4b3eb8871ce
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 19, 2017
Package DI Number
10015482540019
Quantity per Package
4
Contains DI Package
00015482540012
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |