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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: PRISMA TPE 2000 SET; PRISMAFLEX TPE 2000 SET
Classification Name: SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
Product Code: MDP
Device Class: 3
Registered Establishment Name: GAMBRO RENAL PRODUCTS, INC.
Registered Establishment Number: 2087532
Owner/Operator: Gambro Renal Products, Inc.
Owner/Operator Number: 9038727
Establishment Operations: Manufacturer
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