| Primary Device ID | 00860010611906 |
| NIH Device Record Key | 93c5251f-a076-417c-a672-c0882d168a99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RGS |
| Version Model Number | RGS |
| Company DUNS | 603751798 |
| Company Name | Genesis Air, Inc. |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
|---|---|
| GS1 | 00860010611906 [Primary] |
| FRA | Purifier, Air, Ultraviolet, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-26 |
| Device Publish Date | 2023-07-18 |
| 00860010611906 - RGS | 2023-07-26The RGS is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. The RGS have demonstrated the ability to deactivate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. |
| 00860010611906 - RGS | 2023-07-26 The RGS is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air b |
| 00860010611913 - RGS mini | 2023-07-26 The RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the |