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DISCLAIMERS
*The Seraph® 100 Microbind® Affinity Blood Filter (Seraph) is CE Marked and approved for commercial sale in EU member states.
**Emergency Use Authorization Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is for use in the United States under FDA EUA200165:
Authorization for Emergency Use in patients with COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.
The Seraph 100 device has neither been cleared or approved for the indication to treat patients with COVID-19 infection.
The Seraph 100 device has been authorized by FDA under an Emergency Use Authorization (EUA).
The Seraph 100 device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph device 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.