Company:Baxter Healthcare Renal DivisionDate of Enforcement Report 12/3/2009 Class:ll PRODUCT System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by...Read More