FDA UDI
In Commercial Distribution
🇺🇸 United States
AIR INNOVATIONS
DI: 00180104009441
·
Model: MH-901DA
·
GREAT INNOVATIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- AIR INNOVATIONS
- Primary DI
- 00180104009441
- Version / Model
- MH-901DA
- Company Name
- GREAT INNOVATIONS, LLC
- Labeler DUNS
- 603158390
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-15
- Public Version
- 2
- Public Version Date
- 2021-07-19
- Public Version Status
- Update
- Public Device Record Key
- 88da1114-87c6-4d03-8bf0-716139cd39eb
Device Description
Clean Mist 1.6G Top Fill Digital Humidifier with Aroma Tray - Platinum
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | Anesthesiology | 868.5460 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16759 | Room humidifier | A mains electricity (AC-powered) device intended to add moisture to ambient air, typically to prevent dryness of a patient's airways. This is a stationary device designed to be placed in one location in a room, typically in a hospital, institution, home, or office environment; it can be physically lifted and moved to another position or room. It typically consists of an electric motor, a reservoir for water, an atomizer to produce large mist particles, and a flow diverter. The water reservoir is periodically topped up with clean (preferably purified) water. Moisture is released directly into the room's atmosphere. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10180104009448 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 00180104009441 | GS1 | ||||
| Package | 20180104009445 | GS1 | case | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 844-600-1370
- [email protected]