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Smart Anemia Manager (SAM)

Dosis Inc. · Model 1 · UDI-DI 00860005737512

MQS Prescription

510(k) clearances

271

Adverse events (12 deaths)

Recalls

Facilities

Description

SAM is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin (Hgb) levels in hemodialysis patients. The device is intended to help clinicians manage chronic anemia.

Recalls

Date	Firm	Reason
2015-02-17	Transonic Systems Inc	Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displ

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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.