MarCor ENX - The MarCor ENX is intended to be used to filter - NEPHROS, INC.

Duns Number:120664557

Device Description: The MarCor ENX is intended to be used to filter water or bicarbonate concentrate used in h The MarCor ENX is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).Use: The device is intended for long term continuous use. Once it completes its useful life, the filter should be replaced and discarded. Do not attempt to sterilize or reuse it.CONTRAINDICATIONSMedical: While the MarCor ENX produces ultrapure water, the water is not intended to be used in medical applications where USP sterile water is normally used.Chemical: The MarCor ENX retains biological contaminants. To obtain chemically pure water it is necessary to use the filter in conjunction with other devices such as DI beds or RO systems.

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More Product Details

Catalog Number

70-0251M

Brand Name

MarCor ENX

Version/Model Number

3030047

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Device Record Status

Public Device Record Key

aae08fad-b49c-4584-9557-23efbbaa7277

Public Version Date

August 27, 2019

Public Version Number

4

DI Record Publish Date

July 18, 2017

Additional Identifiers

Package DI Number

10896241002739

Quantity per Package

1

Contains DI Package

00896241002732

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

1 part per box

"NEPHROS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25