inforMED
NHVClass II

System, Water Purification, General Medical Use

Gastroenterology, Urology · 21 CFR 876.5665

The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.

MDR events9All time
Recalls0All time
Registered firms26Currently listed
510(k) clearances11All time

Recent MDR events

9 adverse event reports on file

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Event type breakdown

Malfunction8
Injury1

Most-reported manufacturers

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Nephros6Nephros Inc1Nephros, Inc.1Pall Corporation1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

26 firms currently registered for this product code

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510(k) clearances

11 clearances for this product code

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