| Primary Device ID | B236ATL2022110 |
| NIH Device Record Key | 91b86219-afa6-417f-bb1e-a75b74fd6bdb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sunquest Atlas |
| Version Model Number | 2022.1 MR1 |
| Company DUNS | 052934841 |
| Company Name | CliniSys, Inc |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| HIBCC | B236ATL2022110 [Primary] |
| JQP | Calculator/Data Processing Module, For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-31 |
| Device Publish Date | 2023-07-21 |
| B236SQBB202410 - Clinisys SQ Blood Bank | 2024-12-16 Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: †|
| B236SQLAB202410 - Clinisys SQ Lab | 2024-12-16 Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory. Clinisys SQ Lab is intended for use only |
| B236CATL202340 - Clinisys Atlas | 2024-12-05 Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of |
| B236CLS202330 - Clinisys Laboratory Solution | 2024-11-04 The Clinisys Laboratory Solution (CLS) is a laboratory information management system that is used to manage laboratory work. The |
| B236CLS202320 - Clinisys Laboratory Solutions | 2024-08-20 The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. Th |
| B236CATL202330 - Clinisys Atlas | 2024-05-10 Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of |
| B236CLS2023200 - Clinisys Laboratory Solutions | 2024-05-10 The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. Th |
| B236CLS20232140 - Clinisys Laboratory Solutions | 2024-03-26 The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. Th |