| Primary Device ID | 10896241002227 |
| NIH Device Record Key | 738eec88-78af-413a-a204-bbde603660b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SSU Dome Dialysis |
| Version Model Number | 70-0243D |
| 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 | 00896241002220 [Primary] |
| GS1 | 10896241002227 [Package] Contains: 00896241002220 Package: Filter Box [1 Units] In Commercial Distribution |
| GS1 | 20896241002224 [Package] Package: Carton Box [12 Units] In Commercial Distribution |
| FIP | Subsystem, Water Purification |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-24 |
| Device Publish Date | 2021-09-16 |
| 10896241002210 | SSU Dome Dialysis and packaging information |
| 10896241002227 | The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemo |