COOK REGENTEC

COOK REGENTEC - HemaTrate® Blood Filtration system

HemaTrate® Blood Filtration System (Cook Regentec) is designed for use in the clinical laboratory, or intra-operatively at the point of care, for the rapid preparation of a total nucleated cell concentrate (TNC) from 20-120 ml of anticoagulated blood for use in human cell therapy applications.

HemaTrate® Blood Filtration System is a proprietary gravity-based selective filtration technology that separates specific cell populations, useful for the concentration of total nucleated cell concentrate from anticoagulated peripheral whole blood.

During production, filters are subjected to conformity and integrity control tests. All the materials of the parts intended for contact with fluids meet the in vitro biological reactivity tests USP 88 and/or the relevant sections of the series of ISO 10993 standards. The system is designed and manufactured according to quality systems compliant with ISO 9001: 2015 and ISO 13485: 2016 and the Directive 93/42/EEC for Medical Devices.

The HemaTrate® Blood Filtration System device is contained in the HemaTrate® Procedure Pack produced by Betatex Spa on Athena specifications.

HemaTrate® Procedure Pack is a sterile, assembled kit complete with required accessories for product use, supporting consistent procedural technique while considering the patient’s biological variables

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