Disclaimers
The CAPIOX EBS has neither been cleared or approved for providing long-term
(> 6 hours) respiratory or cardiopulmonary support to treat patients 18 years or
older with Coronavirus Disease 2019 (COVID-19) who have acute respiratory
failure or acute cardiopulmonary failure, where other available treatment options
have failed, and continued clinical deterioration is expected or the risk of death
is imminent; and,
The CAPIOX EBS has been authorized for the above emergency use by FDA
under an EUA; and,
The CAPIOX EBS has been authorized only for the duration of the declaration
that circumstances exist justifying the authorization of the emergency use of
medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
Contact Information
Product Surveillance can be reached at 800-521-2818 x6066 or
tcvs.aacomplaints@terumomedical.com
Customer Service can be reached at 800-521-2818 x6929 or
cvscustomerservice@terumomedical.com
Tech Support can be reached at 800-521-2818 x6932 or
tech.support@terumomedical.com
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