| Primary Device ID | 00896241002732 |
| NIH Device Record Key | aae08fad-b49c-4584-9557-23efbbaa7277 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MarCor ENX Hollow Fiber Capsule UltraFilter |
| Version Model Number | W2T912244 |
| Catalog Number | 70-0251M |
| Company DUNS | 120664557 |
| Company Name | NEPHROS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00896241002732 [Primary] |
| GS1 | 10896241002739 [Package] Package: Filter Box [1 Units] In Commercial Distribution |
| GS1 | 20896241002736 [Package] Contains: 10896241002739 Package: Carton Box [10 Units] In Commercial Distribution |
| FIP | Subsystem, Water Purification |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00896241002732]
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| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-02-14 |
| Device Publish Date | 2017-07-18 |
| 00896241002237 - Nephros SSUmini UltraFilter | 2024-11-11 The Nephros SSUmini UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. |
| 00896241002244 - Nephros SSUmini UltraFiltro | 2024-11-11 The Nephros SSUmini UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. |
| 10896241002616 - Nephros SSUmini JG UltraFilter | 2024-11-11 The Nephros SSUmini JG UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis device |
| 10896241002623 - Nephros SSUmini JG UltraFiltro | 2024-11-11 The Nephros SSUmini JG UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis device |
| 00896241002732 - MarCor ENX Hollow Fiber Capsule UltraFilter | 2024-02-14The MarCor ENX Hollow Fiber Capsule UltraFilter 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. CONTRAINDICATIONS Medical: 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. |
| 00896241002732 - MarCor ENX Hollow Fiber Capsule UltraFilter | 2024-02-14 The MarCor ENX Hollow Fiber Capsule UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodi |
| 10896241002098 - DSU-H Quick Connect (Polypropylene) | 2022-03-21 The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter |
| 10896241002104 - DSU-H Thread (Polyproplyene) | 2022-03-21 The Nephros DSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter |
| 10866318000388 - EndoPur Endotoxin 10" Filter | 2021-09-24 Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from flu |