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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 NameLIXELLE® ß2-microglobulin Apheresis Column (LIXELLE® S-15 (150 mL capacity) (LIXELLE® S-25 (250 mL capacity) (LIXELLE® S
Classification Namebeta 2-microglobulin apheresis column
Generic Namebeta 2-microglobulin apheresis column
Applicant
Kaneka Pharma America, LLC
546 fifth ave., 21st floor
new york, NY 10036
HDE NumberH130001
Supplement NumberS005
Date Received01/29/2026
Decision Date04/09/2026
Product Code
PDI[ Registered Establishments with PDI ]
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 modifications of the device design by replacing the outlet cap with an existing cap currently used at another inlet port as well as changes to the acceptance criteria for air inspection in the product.
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