Address:Yousuien-nai,Kamigyo-ku Kyoto,JP
Device Description : Assure ID PRO Safety Pen Needles are disposable, sterile needles intended for us 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.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Assure ID DUO PRO Safety Pen Needles are disposable, sterile needles intended fo 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.
Device Class : 2
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Assure ID DUO PRO Safety Pen Needles are disposable, sterile needles intended fo 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.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Insulin Safety Pen Needle. Intended to be used with a pen injector device for t Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Insulin Safety Pen Needle. Intended for use with a pen injector device for the 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.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Portable Blood Glucose Meter
Device Class : 2
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Assure Dose Normal (Level 1) Control Solution contains a known amount of glucose 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.)
Device Class : 1
Duns Number: 008171162
Premarket Exempt : Yes
Prescription Use : No
Device Description : Assure Dose Normal (Level 1), High (Level 2) Control Solution contains a known a 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.)
Device Class : 1
Duns Number: 008171162
Premarket Exempt : Yes
Prescription Use : No
Device Description : Blood Glucose Test Strips
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Blood Glucose Test Strips
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No