ARKRAY USA, INC.

Address:Yousuien-nai,Kamigyo-ku Kyoto,JP

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Device Description : For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Co 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.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Device Description : For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Co 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.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Device Description : The GLUCOCARD W Blood Glucose Monitoring System is intended for the quantitative 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.

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Device Description : GLUCOCARD W Blood Glucose Test Strips are for use with the GLUCOCARD W blood glu 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.

Device Class :

Duns Number: 008171162

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 50

Device Description : Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle 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.

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : MEG

Prescription Use : No

Device Count : 1

Device Description : Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle 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.

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : MEG

Prescription Use : Yes

Device Count : 1

Device Description : Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle 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.

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : MEG

Prescription Use : Yes

Device Count : 1

Device Description : Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle 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.

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : MEG

Prescription Use : Yes

Device Count : 1

Device Description : Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle 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.

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : MEG

Prescription Use : Yes

Device Count : 1

Device Description : Portable Blood Glucose Meter

Device Class :

Duns Number: 008171162

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1