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5-PLASMA Bivalirudin Control

Model 5D-44905 · 5-Diagnostics Ltd · DI 05070002420385

GGN — Plasma, Coagulation Control · Class II · 21 CFR 864.5425

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

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Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

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Manufacturer compliance record — 5-Diagnostics Ltd

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