| Primary Device ID | 00860003054901 |
| NIH Device Record Key | 0e0fea1d-e853-4e90-acc9-0224abc217d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLR Irrigator |
| Version Model Number | S012-01-019 |
| Company DUNS | 080279373 |
| Company Name | CLR Medical |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003054901 [Primary] |
| GS1 | 00860003054987 [Package] Package: [5 Units] In Commercial Distribution |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-06 |
| Device Publish Date | 2024-05-29 |
| 00850052377021 - CLR Port Injector | 2024-06-06 |
| 00860003054901 - CLR Irrigator | 2024-06-06 |
| 00860003054901 - CLR Irrigator | 2024-06-06 |
| 00860003054956 - CLR Port | 2024-06-06 |
| 00850052377014 - CLR Port Cap | 2024-06-06 |
| 00860003054949 - CLR Medical | 2021-11-15 |