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ARKRAY USA, INC.

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GLUCOCARD® Shine Express Blood Glucose Monitoring System
ARKRAY USA, INC.
The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
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GLUCOCARD® Shine Connex Blood Glucose Monitoring System
ARKRAY USA, INC.
The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
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GLUCOCARD® Shine XL Blood Glucose Monitoring System
ARKRAY USA, INC.
The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
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GLUCOCARD® Shine Blood Glucose Monitoring System
ARKRAY USA, INC.
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.
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GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS
ARKRAY USA, INC.
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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GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS
ARKRAY USA, INC.
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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GLUCOCARD® Shine Level 2 Control Solution
ARKRAY USA, INC.
GLUCOCARD Shine Level 2 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540074 is used as the assigned UDI for the Class I device.)
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GLUCOCARD® Shine Level 1 Control Solution
ARKRAY USA, INC.
GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540050 is used as the assigned UDI for the Class I device.)
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GLUCOCARD® Shine Blood Glucose Monitoring System
ARKRAY USA, INC.
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.
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ASSURE® Prism Blood Glucose Test Strips
ARKRAY USA, INC.
Blood Glucose Test Strips, Individually Foiled
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ASSURE® PRISM MULTI BLOOD GLUCOSE TEST STRIPS
ARKRAY USA, INC.
Blood Glucose Test Strips
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Assure® Prism Control Solution
ARKRAY USA, INC.
Assure Prism Control Solution contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482530068 is used as the assigned UDI for the Class I device.)
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ASSURE® PRISM MULTI BLOOD GLUCOSE METER
ARKRAY USA, INC.
Portable Blood Glucose Meter
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ASSURE® ID TB SAFETY SYRINGE 1mL 31G x 5/16"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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ASSURE® ID TB SAFETY SYRINGE 1mL 28G x 1/2"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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ASSURE® ID TB SAFETY SYRINGE 1mL 27G x 1/2"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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ASSURE® ID TB SAFETY SYRINGE 1mL 25G x 5/8"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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ASSURE® ID TB SAFETY SYRINGE 1mL 25G x 1"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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GLUCOCARD® W Blood Glucose Test Strips
ARKRAY USA, INC.
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.
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GLUCOCARD® W Blood Glucose Monitoring System
ARKRAY USA, INC.
The GLUCOCARD W 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 the palm. For single-patient use only.
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Assure® Control Level 3 Control Solution (High)
ARKRAY USA, INC.
For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly.
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Assure® Control Level 2 Control Solution (Normal)
ARKRAY USA, INC.
For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly.
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Assure® Control Level 1 Control Solution (Low)
ARKRAY USA, INC.
For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly.
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ASSURE® ID INSULIN SAFETY SYRINGE .5mL 31G x 5/16"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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ASSURE® ID INSULIN SAFETY SYRINGE .3mL 31G x 5/16"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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ASSURE® ID INSULIN SAFETY SYRINGE 1mL 31G x 5/16"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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ASSURE® ID Safety Syringe .5mL 29G x 1/2"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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ASSURE® ID INSULIN SAFETY SYRINGE .3mL 29G x 1/2"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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ASSURE® ID Safety Syringe 1mL 29G x 1/2"
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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Assure® Platinum
ARKRAY USA, INC.
Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (in vitro diognostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as a aid to monitor the effectiveness of diabetes control.
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Assure® Dose Normal (Level 1) Control Solution
ARKRAY USA, INC.
Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with CS insert.)
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Assure® Dose Normal (Level 1) Control Solution
ARKRAY USA, INC.
Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with logbook and CS insert.)
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Assure® Platinum BLOOD GLUCOSE TEST STRIPS
ARKRAY USA, INC.
Blood Glucose Test Strips
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Assure® Platinum BLOOD GLUCOSE TEST STRIPS
ARKRAY USA, INC.
Blood Glucose Test Strips
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Assure® Dose Normal/High Control Solution
ARKRAY USA, INC.
Assure Dose Normal (Level 1), High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500061 is used as the assigned UDI for the Class I device.)
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Assure® Dose Normal (Level 1) Control Solution
ARKRAY USA, INC.
Assure Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500054 is used as the assigned UDI for the Class I device.)
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Assure® Platinum BLOOD GLUCOSE METER
ARKRAY USA, INC.
Portable Blood Glucose Meter
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Assure® ID Safety Pen Needles, 30G x 8mm Sample 10's
ARKRAY USA, INC.
Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the safety shield automatically covers the needle to minimize the risk of accidental needle sticks.
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Assure® ID Safety Pen Needle 8mm x 30g 100's
ARKRAY USA, INC.
Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
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Assure® ID DUO PRO Safety Pen Needles 31gx5mm 100's
ARKRAY USA, INC.
Assure ID DUO PRO Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks.
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Assure® ID DUO PRO Safety Pen Needles 31gx5mm Sample 10's
ARKRAY USA, INC.
Assure ID DUO PRO Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks.
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Assure® ID PRO Safety Pen Needles 30gx5mm 100's
ARKRAY USA, INC.
Assure ID PRO Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks.
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Assure® ID Safety Pen Needle 5mm x 31g 100's
ARKRAY USA, INC.
Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
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Assure® ID Safety Pen Needle 5mm x 30g 100's
ARKRAY USA, INC.
Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
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Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10's
ARKRAY USA, INC.
Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks.
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Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 10's
ARKRAY USA, INC.
Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks.
0
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Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 100's
ARKRAY USA, INC.
Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks.
0
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Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 100's
ARKRAY USA, INC.
Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks.
0
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Assure® ID Safety Pen Needles, 30G x 5mm Sample 10's
ARKRAY USA, INC.
Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the safety shield automatically covers the needle to minimize the risk of accidental needle sticks.
0
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Assure® ID INSULIN SAFETY SYRINGE 0.5mL 31G x 6mm
ARKRAY USA, INC.
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.