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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device platelets, photochemical treatment system
Definition The photochemical treatment system is a class iii medical device for the preparation and storage of pathogen reduced donor derived platelets. The device has the process capability for the pathogen inactivation of platelets having platelet counts of 2.5-6.0x1011. The platelet products are indicated for support of patients requiring platelet transfusion according to clinical practice guidelines. There is no intended pharmacological effect attributed to residual amotosalen (s-59) in the platelet product.
Product CodeNJN
Device Class 3