Duns Number:008171162
Device Description: GLUCOCARD W Blood Glucose Test Strips are for use with the GLUCOCARD W blood glucose meter GLUCOCARD W Blood Glucose Test Strips are for use with the GLUCOCARD W blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the palm. Alternative site testing (AST) should only be used during steady-state blood glucose conditions. The GLUCOCARD W blood glucose monitoring system is intended for self-testing outside the body (in vitro) by people with diabetes as an aid to monitor the effectiveness of diabetes control. This system is not intended for use on neonates, and it is not for the diagnosis or screening of diabetes.
Catalog Number
-
Brand Name
GLUCOCARD® W Blood Glucose Test Strips
Version/Model Number
512050
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170064,K170064,K170064,K170064
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
63a30c9f-7fc3-4643-8735-1dca478f85db
Public Version Date
April 09, 2019
Public Version Number
1
DI Record Publish Date
April 01, 2019
Package DI Number
20015482512051
Quantity per Package
18
Contains DI Package
10015482512054
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Shipper
| 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 |