NHV

Product Code: NHV

Products Classified as NHV

2017

System, Water Purification, General Medical Use

Water Purification System For Hemodialysis.

Total Product Life Cycle (TPLC) Devices

2017

System, Water Purification, General Medical Use

Water Purification System For Hemodialysis.

FDA Consensus Standards

• System, Water Purification, General Medical Use [36807]: 21 CFR §876.5665 🔎
• System, Water Purification, General Medical Use [36809]: 21 CFR §876.5665 🔎
• System, Water Purification, General Medical Use [36808]: 21 CFR §876.5665 🔎

Pre-market Notifications for NHV

K191563	FILTRAY 2G Disposable Water Filters	Aqua-tools
K182164	Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand	Ecolab Inc.
K173164	Ecolab POU Water Filter	Ecolab Inc.
K163609	Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)	PALL INTERNATIONAL SARL
K161467	HydraGuard 10 UltraFilter	NEPHROS INC.
K153784	NOSOGARD FILTERS	Evoqua Water Technologies, LLC
K153434	Pall-Aquasafe Water Filter	PALL INTERNATIONAL, SARL
K153084	Nephros S100	NEPHROS INC.
K141731	NEPHROS DSU-H, NEPHROS SSU-H	NEPHROS, INC.
K012716	MAINSTREAM WATER PURIFICATION DEVICE	PRISMEDICAL CORP.

Global Unique Device Identification Database

• 20866318000347: System, Water Purification, General Medical Use
• 20866318000330: System, Water Purification, General Medical Use
• 10866318000326: System, Water Purification, General Medical Use
• 05034480315670: System, Water Purification, General Medical Use
• 05034480315663: System, Water Purification, General Medical Use
• 05034480315656: System, Water Purification, General Medical Use
• 05034480315649: System, Water Purification, General Medical Use
• 35034480315534: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
• 35034480315527: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
• 35034480315510: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
• 35034480315503: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
• 35034480314803: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
• 35034480313752: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
• 35034480313745: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
• 35034480313691: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE

Maude Adverse Events

NEPHROS	NEPHROS	2019-05-29
FALL MEDICAL Q POINT STERILIZING GRADE WATER FILTER	PALL CORPORATION	2018-11-02
DSU-H	NEPHROS INC	2018-04-04
DSU-D	NEPHROS, INC.	2017-12-13