| Primary Device ID | 05060497260078 |
| NIH Device Record Key | 2615b1cf-b4d9-40f6-8b70-4428380aa556 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Home Water Cart |
| Version Model Number | SC-14615 |
| Company DUNS | 211298693 |
| Company Name | QUANTA DIALYSIS TECHNOLOGIES LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 05060497260078 [Primary] |
| MON | System, Hemodialysis, Remote Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-03-10 |
| Device Publish Date | 2023-01-05 |
| 05060497260160 - Quanta Dialysis System | 2023-08-31 Quanta Dialysis System Hemodialysis Delivery Device |
| 15060497260167 - Quanta Dialysis System | 2023-07-11 Quanta Dialysis System Hemodialysis Delivery Device |
| 05060497260078 - Home Water Cart | 2023-03-10Home Water Cart (US) |
| 05060497260078 - Home Water Cart | 2023-03-10 Home Water Cart (US) |
| 05060497260016 - SC+ Haemodialysis System | 2021-11-04 SC+ Blood Tube Set |
| 05060497260047 - SC+ Dialysate Cartridge | 2021-11-04 SC+ Dialysate Cartridge |
| 05060497260085 - SC+ Hemodialysis Machine | 2021-11-04 SC+ Hemodialysis Delivery Device |
| 05060497260061 - Cart | 2021-10-05 |
| 05060497260023 - SC+ Haemodialysis System | 2021-06-29 SC+ Dialysate Cartridge |