| Primary Device ID | B236CATL202340 |
| NIH Device Record Key | ad5213aa-e409-450c-9cd9-0e0fdd507a52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clinisys Atlas |
| Version Model Number | 2023.4 |
| 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 | B236CATL202340 [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 | 2024-12-05 |
| Device Publish Date | 2024-11-27 |
| B236ATL2023100 | Clinisys Atlas is a solution set comprised of four solutions that can be activated individually |
| B236CATL202320 | Clinisys Atlas is a solution set comprised of four solutions that can be activated individually |
| B236CATL202330 | Clinisys Atlas is a solution set comprised of four solutions that can be activated individually |
| B236CATL202340 | Clinisys Atlas is a solution set comprised of four solutions that can be activated individually |