AK 98 Hemodialysis Machine
Amia with Sharesource
Homechoice Claria with Sharesource
Phoenix X36 Hemodialysis System
Polyflux 6H Dialyzer
Emergency Use Authorization
Baxter Healthcare Corporation has received several Emergency Use Authorizations for products to treat certain patients with confirmed COVID-19 infection. Please see Emergency Use Authorizations and Intended Use statements for each of these disposable products. FDA has not cleared or approved the EUA products for treatment of COVID-19 patients. Rather, the EUAs authorize use of the products for no longer than the duration of the COVID-19 public health emergency.
Oxiris Filter Set
Prismaflex HF20 Set
Prismaflex ST Set
REGIOCIT solution has been authorized by FDA for emergency use. REGIOCIT solution is not FDA-approved. REGIOCIT solution has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of REGIOCIT solution under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.