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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Capiox® iCP Centrifugal Pump
Classification Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Product Code: KFM
Device Class: 2
Regulation Number: 870.4360
Medical Specialty: Cardiovascular
Registered Establishment Name: Sterigenics U.S., LLC
Registered Establishment Number: 1319639
Owner/Operator: Sotera Health LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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