Prismaflex HF20 Set

The Prismaflex HF20 Set has been Authorized by the FDA to provide continuous renal replacement therapy (CRRT) to treat low weight (8-20 kg) and low blood volume patients or patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the Coronavirus Disease 2019 (COVID-19) pandemic. The Prismaflex HF20 Set has neither been cleared or approved to provide CRRT in an acute care environment. The Prismaflex HF20 Set has been authorized by FDA under EUA201769. The Prismaflex HF20 Set is Authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Prismaflex HF20 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.

RX Only. For safe and proper use of the products mentioned herein, please refer to the Operator's Manual or Instructions for Use.

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