HydraGuard 10" UltraFilter - Flush

GUDID 20866318000347

Description: The HydraGuard 10” UltraFilter - Flush is a hollow fiber ultrafilter that retains bacteria, viruses, and endotoxin from water. Indications for Use: The HydraGuard 10” UltraFilter - Flush is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands. The filter is not intended to provide wa

NEPHROS, INC.

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Primary Device ID20866318000347
NIH Device Record Keye744af4c-95e0-4c73-b886-29cd4ef377bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydraGuard 10" UltraFilter - Flush
Version Model Number70-0112
Company DUNS120664557
Company NameNEPHROS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com
Phone201-345-0829
Emailvashone.thomas@nephros.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100866318000343 [Primary]
GS110866318000340 [Package]
Contains: 00866318000343
Package: Single box, one part [1 Units]
In Commercial Distribution
GS120866318000347 [Package]
Contains: 10866318000340
Package: box of 30 single box [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHVSystem, Water Purification, General Medical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-15
Device Publish Date2017-12-31

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