RGS; RGS Mini
Genesis Air, Inc.
GENESIS AIR, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3027534461 | 3027534461 | GENESIS AIR, INC. | 1 | N | 2026-01-01 | 5202 CR 7350 Suite D Lubbock TX US 79424 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 318636 | 1503379223 | K222702 | RGS; RGS Mini | FRA | 2023-06-02 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FRA | 1 | 2023-06-02 |
PMN#
GUDID#
RGS - The 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.
2023-07-18
RGS mini - The RGS mini 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 mini 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.
2023-07-18