U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Emergency Situations (Medical Devices)
  5. Emergency Use Authorizations for Medical Devices
  6. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
  7. Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs

Continuous renal replacement therapy (CRRT) devices are used to filter and clean the blood when kidneys are damaged or not functioning normally. Based on published data, it has been noted that SARS-CoV-2, the virus that causes COVID-19, has led to an increased population with critical illness and multiple organ failure, including acute kidney injury, increasing the need for CRRT. Devices authorized by these EUAs include the hemodialyzer/hemofilter, delivery unit, bloodlines and tubing, and dialysate solution.

The table below lists the authorization information for the use of specific CRRT and hemodialysis devices during the COVID-19 public health emergency.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.

Date EUA Issued Letter of Authorization Assigned Product Code Fact Sheets Other Documents
04/30/2020 Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions QLP
05/20/2020 Baxter Healthcare Corporation, Prismaflex ST Set QLP
08/10/2020 Baxter Healthcare Corporation, Prismaflex HF20 Set QLP

 

Back to Top