FDA UDI
In Commercial Distribution
🇺🇸 United States
ADS
DI: 06971608312533
·
Model: Thor
·
Guangzhou Ajax Medical Equipment Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ADS
- Primary DI
- 06971608312533
- Version / Model
- Thor
- Company Name
- Guangzhou Ajax Medical Equipment Co., Ltd.
- Labeler DUNS
- 547897476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-22
- Public Version
- 1
- Public Version Date
- 2026-04-30
- Public Version Status
- New
- Public Device Record Key
- 2d73e897-613c-4f9e-865c-e7926cfd7ab7
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRA | Purifier, Air, Ultraviolet, Medical | General Hospital | 880.6500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65418 | Ultraviolet-activated air cleaner | An air purification device intended to destroy airborne pathogens and pollutants (e.g., volatile organic compounds) in the ambient air of an enclosed room/area using ultraviolet (UV) radiation light applied to the air before being ventilated/recirculated to the room. It consists of an electrically-powered unit with an enclosed optic chamber in which air is exposed to UV energy whereby disinfection is achieved through hydroxyl radicals (produced by the reaction between UV energy and water vapour), or by a UV-activated photocatalyst (e.g., titanium dioxide). It may be a floor-standing device or a unit integrated into the facility ventilation system, and may include air filters (e.g., HEPA). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971608312533 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202766 | 000 |