FDA.reportPublic FDA data

EXIN

Primary DI
04719871893319
Brand
EXIN
Company
FOREMOUNT ENTERPRISE CO., LTD.
Model
MAT1563
Device description
Humidifier 350 ml, large Volume Nebulizer
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04719871893319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871893319047198718933194719871893319

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658718465
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871896730Aero US1FAXX-00772026-02-12
04719871896747Aero US1FAXX-01012026-02-12
04719871896754Aero US1FAXX-01182026-02-12
04719871896761Aero US1FCXX-00242026-02-12
04719871896778Aero US1FCXX-00262026-02-12
04719871896785Aero US1FDXX-00312026-02-12
04719871896792Aero US1FM4A-00252026-02-12
04719871896808Aero US1FM4A-00352026-02-12
04719871897874KEMP USA10-5012026-02-12
04719871897881KEMP USA10-501-SE2026-02-12
04719871897898KEMP USA10-5252026-02-12
04719871897904KEMP USA10-525-NL2026-02-12
04719871897911KEMP USA10-5262026-02-12
04719871897928KEMP USA10-5142026-02-12
04719871897935Code One1FAXX-00162026-02-12
04719871897942Code One1FAXX-01092026-02-12
04719871892251JBC400-1046/252024-07-18
04719871890011WNLME6201B-FAK5000GIRED2024-06-28
04719871890028WNLME6201NB2-FAK5000SGI2024-06-28
04719871890042WNLME6201NB12-FAK5000SG2024-06-28

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
00328785002454VicksKAZ, INC.KFZ2025-05-05
00328785002478VicksKAZ, INC.KFZ2025-05-05
00851440007704Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.KFZ2024-08-01