Identity
- Trade Name
- RGS FDA UDI
- Generic Name
- Ultraviolet-activated air cleaner FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- RGS FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010611906 FDA UDI
- 510(k) Number
- K222702 FDA UDI
- FDA Product Code
- FRA FDA UDI
- GMDN Term
- Ultraviolet-activated air cleaner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultraviolet-activated air cleaner
Rgs by Genesis Air, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultraviolet-activated air cleaner.
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- VIDASHIELD/UV24 — Medical Illumination International, Inc · Class I
- Airgle — AIRGLE CORPORATION · Class II
- VIDASHIELD/UV24 — Medical Illumination International, Inc · Class I
- VIDASHIELD/UV24 — Medical Illumination International, Inc · Class I
- The Pyure Company — The Pyure Company Inc · Class II
- Airgle — AIRGLE CORPORATION · Class II
Cleared under the same submission
K222702 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Genesis Air, Inc.
Sources (1)
- FDA UDI 93c5251f-a076-417c-a672-c0882d168a99 34 fields · synced Jun 8, 2026