Device typeIn vitro ionizing-radiation blood irradiator: An electrically-powered device designed for the in vitro irradiation of blood and/or blood components with ionizing radiation (e.g., gamma, x-ray), typically for the prevention of transfusion-associated graft-versus-host diseases and pathogen transmission, and/or for cancer treatment; some types may be additionally used to irradiate other specimen types (e.g., tissues, organs). It operates off-line (i.e. blood is not returned to the patient in a closed-circuit) and typically includes a shielded, double encapsulated, long half-life radiation source (e.g., Cesium 137), blood/blood product containers, safety interlocks, a timing mechanism, and a means of retrieving samples.
FDA categoryIrradiator, Blood To Prevent Graft Versus Host Disease
Device ID00860000737005
MRI safetyLabeling does not contain MRI Safety Information