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POLYFLUX

Gambro Dialysatoren GmbH · Model 10LR · UDI-DI 07332414047108

MSF KDI FJI Prescription

510(k) clearances

1,219

Adverse events (3 deaths)

Recalls

Facilities

Description

The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.