| Primary Device ID | 05425030421031 |
| NIH Device Record Key | 2d78ccff-d28e-4a54-9457-bc936e868c25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IDS-iSYS Wash Solution (Wash S) |
| Version Model Number | IS-CW100 |
| Company DUNS | 372668418 |
| Company Name | Immunodiagnostic Systems SA |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | +32042522636 |
| info.be@idsplc.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05425030421031 [Primary] |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-04-01 |
| 05425030421024 - IDS-iSYS Trigger Set | 2019-12-23 |
| 05425030426012 - IDS-iSYS Cartridge Check System (CCS) | 2019-12-23 |
| 05425030421017 - IDS-iSYS System Liquid (Syst. l) | 2018-03-29 |
| 05425030421031 - IDS-iSYS Wash Solution (Wash S) | 2018-03-29 |
| 05425030421031 - IDS-iSYS Wash Solution (Wash S) | 2018-03-29 |