The PRISMAFLEX ST Set has been authorized by the FDA under EUA200704 (Emergency Use Authorization) to provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment during the Coronavirus Disease 2019 (COVID-19) pandemic. The device has neither been cleared or approved to provide CRRT in an acute care environment. The device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the PRISMAFLEX ST Set under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Fact Sheet for Healthcare Providers
PRISMAFLEX ST Set Specifications
PRISMAFLEX ST Set Instructions for Use