Identity
- Trade Name
- Airgle FDA UDI
- Generic Name
- Ultraviolet-activated air cleaner FDA UDI
- Device Name
- The Airgle Clean Room Air Purifier AG900 is a free-standing air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254 nm), intended for the inactivation of indoor airborne aerosols, including bacteria and viruses, in medical facilities and occupied spaces. The Airgle® Air Purifier has been demonstrated to be effective against MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure and operating conditions: Test Item(s): MS2 Bacteriophage Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG900: >4.0 log reduction / 120 minutes FDA UDI
- Model / Reference
- AG900 FDA UDI
- Description
- The Airgle Clean Room Air Purifier AG900 is a free-standing air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254 nm), intended for the inactivation of indoor airborne aerosols, including bacteria and viruses, in medical facilities and occupied spaces. The Airgle® Air Purifier has been demonstrated to be effective against MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure and operating conditions: Test Item(s): MS2 Bacteriophage Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG900: >4.0 log reduction / 120 minutes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013509927 FDA UDI
- 510(k) Number
- K232645 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
Airgle by Airgle Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultraviolet-activated air cleaner.
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- VIDASHIELD/UV24 — Medical Illumination International, Inc · Class I
- 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
- VIDASHIELD/UV24 — Medical Illumination International, Inc · Class I
- VIDASHIELD/UV24 — Medical Illumination International, Inc · Class I
Cleared under the same submission
K232645 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
- Airgle Corporation
Sources (1)
- FDA UDI 948ee592-0db8-4b65-81e5-b76e1376d60f 35 fields · synced Jun 1, 2026