FDA.report

Honeywell

Primary DI
00328785002263
Brand
Honeywell
Company
KAZ USA, INC.
Model
HEV320WWM
Device description
Honywell Evaporative Humidifier
Published
2026-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
KFZHumidifier, Non-Direct Patient Interface (Home-Use)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10328785002260PackageGS11In Commercial Distribution
00328785002263PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
800-477-0457consumerrelations@helenoftroy.com

Regulatory Flags

DUNS number
122612547
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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