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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: GAMBRO PLASMAFILTER, PF2000N
Classification Name: SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
Product Code: MDP
Device Class: 3
Registered Establishment Name: Sterigenics Germany GmbH
Registered Establishment Number: 3002807090
Owner/Operator: Sterigenics International, Inc.
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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