| Primary Device ID | 00852456007078 |
| NIH Device Record Key | 1532b21e-9ea3-4fa3-9d0a-7f099c2885db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Complete Water Treatment System |
| Version Model Number | 001 |
| Company DUNS | 040279650 |
| Company Name | ISOPURE, CORP. |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852456007078 [Primary] |
| FIP | Subsystem, Water Purification |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-09-20 |
| 00852456007108 - Acid Dissolution System | 2024-02-22 Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
| 00852456007115 - Acid Dissolution System | 2024-02-22 Dialysate Concentrate For Hemodialysis (Liquid or Powder) |
| 00852456007009 - MD420 Reverse Osmosis System | 2018-07-06 MD420 Reverse Osmosis System |
| 00852456007016 - MD440 Reverse Osmosis System | 2018-07-06 MD440 Reverse Osmosis System |
| 00852456007023 - MD460 Reverse Osmosis System | 2018-07-06 MD460 Reverse Osmosis System |
| 00852456007030 - MD470 Reverse Osmosis System | 2018-07-06 MD470 Reverse Osmosis System |
| 00852456007047 - MD480 Reverse Osmosis System | 2018-07-06 MD480 Reverse Osmosis System |
| 00852456007054 - MD490 Reverse Osmosis System | 2018-07-06 MD490 Reverse Osmosis System |