GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS - The GLUCOCARD Shine Test Strips are for use with - ARKRAY USA, INC.

Duns Number:008171162

Device Description: The GLUCOCARD Shine Test Strips are for use with the GLUCOCARD Shine Blood Glucose Meter t The GLUCOCARD Shine Test Strips are for use with the GLUCOCARD Shine Blood Glucose Meter to quantitatively measure 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.

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More Product Details

Catalog Number

-

Brand Name

GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS

Version/Model Number

540010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120351,K120351,K120351,K120351

Product Code Details

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Device Record Status

Public Device Record Key

aa8f8c84-ea82-4d77-aa2a-b365de3898fe

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 19, 2017

Additional Identifiers

Package DI Number

20015482540108

Quantity per Package

500

Contains DI Package

10015482540101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Shipper

"ARKRAY USA, INC." Characteristics
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