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 set is the only filter that performs multiple blood purification therapies simultaneously, including continuous renal replacement therapy (CRRT) and the removal of cytokines and inflammatory mediators from the blood.