The device was received for evaluation and successfully passed testing.All devices must meet all quality criteria and manufacturing specifications prior to release.A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release.Available log files were retrieved and analyzed which showed device performance was without deficiency and was unremarkable.There was no indication of a device malfunction from the available information.The nxstage system one user guide supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient.Udi: (b)(4).
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