Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameEXCORIM IMMUNOADSORPTION SYSTEM
Classification Namecolumns, immunoadsorption in extracorporeal systems
Generic Namecolumns, immunoadsorption in extracorporeal systems
Applicant
FRESENIUS MEDICAL CARE
95 hayden ave.
lexington, MA 02420
HDE NumberH970004
Supplement NumberS005
Date Received03/23/2005
Decision Date12/05/2005
Product Code
LQQ
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the use of 0. 04% polyhexamethylene biguanide (phmb) with 0. 03% tryptophan (trp) as a preservative solution for the immunosorba® columnas a replacement for 0. 1% thimerosal.
-
-