| Primary Device ID | 02086827700048 |
| NIH Device Record Key | fbeb2ecb-ae47-4bcd-b198-062e1cd527b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TQE Plus Endotoxin 10" Filter Flat 222 Head |
| Version Model Number | TQE0.005-10P3E |
| 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 | 00086827700040 [Primary] |
| GS1 | 01086827700049 [Package] Contains: 00086827700040 Package: single box [1 Units] In Commercial Distribution |
| GS1 | 02086827700048 [Package] Contains: 00086827700040 Package: outer box [15 Units] In Commercial Distribution |
| FIP | Subsystem, Water Purification |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[02086827700048]
Liquid Chemical
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-15 |
| Device Publish Date | 2017-12-21 |
| 02086827700048 | The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox |
| 10868277000416 | The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox |
| 10868277000447 | The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotox |