The MAKY 21.1 Dialyzer Reprocessing System holds the 510K since September 26, 2003. It has nine (9) operating programs that can be employed as a semiautomatic or completely automated system, linking as many MAKY’s together (maximum 9) as required to function in large facilities or centralized reprocessing centers. The programs are “standard, high efficiency and high flux.” Each of those offers an extended cleaning cycle, if it is determined that a dialyzer requires extra effort to clean. The other three (3) programs are available for the medical director to employ as he chooses, but specifically in anticipation of the availability of hemodiafilters, which have a port for fluid replacement, that may require significant alterations in the approach to reprocessing.
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