| Primary Device ID | 05060497260047 |
| NIH Device Record Key | ebb882b7-930e-49a1-8c20-b20ffdd71b2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SC+ Dialysate Cartridge |
| Version Model Number | SC-14354 |
| Company DUNS | 211298693 |
| Company Name | QUANTA DIALYSIS TECHNOLOGIES LIMITED |
| 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 | true |
| 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 | 05060497260047 [Primary] |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-11-04 |
| Device Publish Date | 2021-06-21 |
| 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 | 2023-03-10 Home Water Cart (US) |
| 05060497260016 - SC+ Haemodialysis System | 2021-11-04 SC+ Blood Tube Set |
| 05060497260047 - SC+ Dialysate Cartridge | 2021-11-04SC+ Dialysate Cartridge |
| 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 |