ACCUCHEK

5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

ACCU-CHEK Compact Plus Test Strips || For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip || 51 count retail strip; 102 count retail strip; 51 count MedBen strip || 51 count Mail Order strip; Sample Kit 16 per case. || The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

Model/Catalog/Part Number:  Accu-Chek Combo Kit mg US/English version, 05458544001  Accu-Chek Combo Kit mg US/Spanish version, 055004686001  Accu-Chek Spirit Combo Replacement Pump US/EN, 05391512001  Accu-Chek Spirit Combo Demo Pump- US, 0539175000

General Hospital and Personal Use Devices

2

No

US Nationwide Distribution in the states of CA, CT, IA, NV, OH, IN, WI, GA, MO, NY, VA, LA, ME, TX, NC, ND, SD, NJ, CO, AL, SC, IL, KY, FL, OR, MN, MD, MS, AR, WV, WA, TN, CT, ID, KS, MI, PA, UT, MA, RI, NM, OK, DE, AZ, NE, MT, NV, WY, AK, and NH.

ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System || Product Usage: || The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.

All units with serial numbers SN02119552 thru SN10006093.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution -- USA and Canada.

Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.

05075572002, 05075599002, 05075602002, 05075629002, Part numbers: 05180848002, 05075246002, 05075530002, 05075548002, 05075556002, 05075564002 these are not finished device part numbers and were not intended for use in the US.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution-USA (nationwide) including the states of AZ, NY, RI, TN, NJ, IN, TX, AL, NV, CA, OR, KY, IL, AR, NM, NE, MD, MO, GA, and SD.

ACCU-CHEK Aviva Nano Blood Glucose Meter || No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representative copy of product labeling that would have been included in a finished device kit is attached. || The Accu-Chek Aviva Nano Blood Glucose meter is intended to be used with Accu-Chek Aviva test strips for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The system is intended to be used by a single person and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

part number 05060311001, 05060303001

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. || Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).