COVID-19 Emergency Use Authorization (EUA) Products

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. 

Also usable across all CRRT modalities, HF20 filtersets are appropriate for low-weight patients and patients with low blood volume. 

The Oxiris Set device is authorized under EUA200164 (Emergency Use Authorization) to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) infection admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification, including use in continuous renal replacement therapy. This device has neither been cleared or approved for the indication to treat patients with COVID-19 infection. The device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Oxiris 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.

The Oxiris filterset performs multiple blood purification therapies simultaneously, including CRRT and the removal of cytokines and inflammatory mediators from the blood.