Baxter HomeChoice/HomeChoice Pro

  • Model / Serial
    *** 1) HomeChoice automated peritoneal dialysis system:  Product Codes: 5C4471 and 5C4471R;  Serial Numbers: All serial numbers;   *** 2) HomeChoice Pro automated peritoneal dialysis system:  Product Codes: 5C8310 and 5C8310R;  Serial Numbers: All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan
  • Product Description
    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. || 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. || The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
  • Source
    USFDA