Identity
- Trade Name
- Airgle FDA UDI
- Generic Name
- Ultraviolet-activated air cleaner FDA UDI
- Device Name
- This cHEPA and Gas & Odor Filter set is a replacement accessory for AG900, covered under AG900's 510(k) K232645. It does not have a separate 510(k). FDA UDI
- Model / Reference
- AF900HC FDA UDI
- Description
- This cHEPA and Gas & Odor Filter set is a replacement accessory for AG900, covered under AG900's 510(k) K232645. It does not have a separate 510(k). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013509996 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
Yes
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
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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 96af0972-f415-4596-8e19-0d84dc2f3899 34 fields · synced Jun 1, 2026