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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Plasmaflo OP-05W(A)
Classification Name: SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
Product Code: MDP
Device Class: 3
Registered Establishment Name: Asahi Kasei Medical MT Corp. Oita Works
Registered Establishment Number: 8010002
Owner/Operator: Asahi Kasei Medical Co., Ltd.
Owner/Operator Number: 10040402
Establishment Operations: Contract Manufacturer
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