Insulin infusion pump (as part of the ACCUCHEK Aviva Combo system)

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
  • Source
    USFDA