| Primary Device ID | 10866318000326 |
| NIH Device Record Key | e381828d-e908-42e4-a0dc-114a581699ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HydraGuard 10" UltraFilter |
| Version Model Number | 70-0111 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00866318000329 [Primary] |
| GS1 | 10866318000326 [Package] Contains: 00866318000329 Package: 1 part per box [1 Units] |
| GS1 | 20866318000323 [Package] Package: 30 boxes per CARTON [30 Units] |
| NHV | System, Water Purification, General Medical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-15 |
| Device Publish Date | 2017-07-19 |
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| 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 | 2024-02-14 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 |