ARKRAY USA, INC.

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

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- Catalog Number :

Device Description : Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucos 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.)

Device Class : 1

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : Assure® Dose High (Level 2) Control Solution contains a known amount of glucose Assure® Dose 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. (Mailer packaged with CS insert.)

Device Class : 1

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

- Catalog Number : N/A

Device Description : Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the qua 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.

Device Class :

Duns Number: 008171162

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 30

- Catalog Number :

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

- Catalog Number :

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

- Catalog Number :

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

- Catalog Number :

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

- Catalog Number :

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

- Catalog Number :

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

- Catalog Number :

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