FDA-Device2013-12-25Class I

Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.

Nephros Inc
Hazard

Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.

Sold states
USA Nationwide Distribution
Affected count
3,367 untis with affected labeling
Manufactured in
41 Grand Ave, N/A, River Edge, NJ, United States
Products
Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0490-2014

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