Gambro Renal Products, Inc.

5 devices in the database

  • Model / Serial
    Lot number 05F0864P. Recall expanded on 04/13/2006 to include 05AXXXXX through 05J2796P
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in AZ, CA, DC, FL, GA, MI, MO, NJ, NY, OH, OR, PA, PR, TX, UT, VA, WI. Military distribution to CA and TX. Foreign distribution to Australia, Canada, Denmark, France, Germany, Hungary, UK.
  • Product Description
    Gambro Prisma HF1000 preset, Part No. 8399050.
  • Model / Serial
    Lot numbers 04K2692P, 05A0754P, 05D1571, 05F0763A, 05F0865, 05F0966, 05F1573G, 05F1574, 05F1675G, 05F2387G, 05F3098G, 05G0556G, 05G0760G, 05G1366G. Recall expanded on 04/13/2006 to include 05AXXXXX through 05J2796P.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in AZ, CA, DC, FL, GA, MI, MO, NJ, NY, OH, OR, PA, PR, TX, UT, VA, WI. Military distribution to CA and TX. Foreign distribution to Australia, Canada, Denmark, France, Germany, Hungary, UK.
  • Product Description
    Gambro Prisma M100 preset, Part No. 8353486.
  • Model / Serial
    Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.
  • Product Description
    Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
  • Model / Serial
    Serial numbers: 11637 thru 12321.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, USA, including VA facilities in GA and NC. Foreign distribution to Canada, Korea and Mexico.
  • Product Description
    Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.
  • Model / Serial
    Serial numbers: PA0101 to PA0681.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.

4 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Gambro Renal Products, Inc., 14143 Denver West Pkwy, Lakewood CO 80401-3116
  • Manufacturer Parent Company (2017)
  • Source
    USFDA