FDA.reportPublic FDA data

Air Innovations

Primary DI
00180104001841
Brand
Air Innovations
Company
GREAT INNOVATIONS, LLC
Model
MH-408
Device description
Air Innovations Clean Mist Ultrasonic Humidifier - Black
Published
2021-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KFZHumidifier, Non-Direct Patient Interface (Home-Use)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFZHumidifier, Non-Direct Patient Interface (Home-Use)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10180104000957PackageGS16In Commercial Distribution
00180104001841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1018010400095710180104000957
00180104001841001801040018411801040018410180104001841

GMDN Terms#

Term, Definition table
TermDefinition
Room humidifierA 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.

Contacts#

Phone, Email table
PhoneEmail
8446001370help@air-innovations.com

Regulatory Flags#

DUNS number
603158390
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00180104001704Air InnovationsMH-701BA2021-07-16
00180104001711Air InnovationsMH-701BA2021-07-16
00180104001810Air InnovationsMH-505A2021-07-16
00180104005214Air InnovationsMH-901DA2021-07-16
00180104005719Air InnovationsMH-4192021-07-16
00180104000264Air InnovationsMH-9082021-07-16
10180104001138Air InnovationsMH-701BA2021-07-16
10180104001145Air InnovationsMH-701BA2021-07-16
10180104001015Air InnovationsMH-505A2021-07-16
10180104000957Air InnovationsMH-4082021-07-16
10180104005211Air InnovationsMH-901DA2021-07-16
10180104005716Air InnovationsMH-4192021-07-16
00180104009069Air InnovationsMH-902S2021-07-16
00180104009076Air InnovationsMH-902S2021-07-16
00180104009588Air InnovationsMH-9082021-07-16
00180104009618Air InnovationsMH-9082021-07-16
00180104009625Air InnovationsMH-7032021-07-16
00180104009632Air InnovationsMH-7032021-07-16
00180104009649Air InnovationsMH-5272021-07-16
00180104009656Air InnovationsMH-3262021-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194346604845EquateWAL-MART STORES, INC.KFZ2026-02-16
00328785008234HONEYWELLKAZ USA, INC.KFZ2026-02-04
00328785008258HoneywellKAZ USA, INC.KFZ2026-02-04
00328785012828VicksKAZ USA, INC.KFZ2026-02-04
00328785101539VicksKAZ USA, INC.KFZ2026-02-04
00328785002263HoneywellKAZ USA, INC.KFZ2026-02-04
10328785008231HONEYWELLKAZ USA, INC.KFZ2026-02-04
10328785008255HoneywellKAZ USA, INC.KFZ2026-02-04
00328785012804VicksKAZ USA, INC.KFZ2026-02-04
00328785012811VicksKAZ USA, INC.KFZ2026-02-04
10328785012825VicksKAZ USA, INC.KFZ2026-02-04
00328785012835VicksKAZ USA, INC.KFZ2026-02-04
10328785101536VicksKAZ USA, INC.KFZ2026-02-04
00328785008241HONEYWELLKAZ USA, INC.KFZ2026-02-03
00050428005583CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-28
00328785009620VICKSKAZ USA, INC.KFZ2026-01-28
00328785013863VicksKAZ USA, INC.KFZ2026-01-28
00328785014426VicksKAZ USA, INC.KFZ2026-01-28
00050428005606CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-26
10050428005603CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-26
00050428005613CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-23
10050428005610CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-23
10889483054338AirLife™SUNMED, LLCKFZ2025-12-19
10889483229422AirLife™SUNMED, LLCKFZ2025-12-19
20889483054335AirLife™SUNMED, LLCKFZ2025-12-19
20889483229429AirLife™SUNMED, LLCKFZ2025-12-19
10889483054321AirLife™SUNMED, LLCKFZ2025-12-18
20889483054328AirLife™SUNMED, LLCKFZ2025-12-18
00328785002454VicksKAZ, INC.KFZ2025-05-05
00328785002478VicksKAZ, INC.KFZ2025-05-05