FDA.reportPublic FDA data

Sunbeam

Primary DI
00053891128414
Brand
Sunbeam
Company
Jarden Consumer Solutions
Model
053891128414
Device description
HLMS COOL MIST HUMIDIFIER W/ AROMA
Published
2019-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
20053891128418PackageGS12In Commercial Distribution
00053891128414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2005389112841820053891128418
00053891128414000538911284140538911284140053891128414

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.

Regulatory Flags#

DUNS number
001315134
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00053891156219Sunbeam0538911562192021-02-25
00053891156226Sunbeam0538911562262021-02-25
00053891181952Sunbeam0538911819522025-12-03
00053891177184Sunbeam0538911771842024-09-10
00053891177207Sunbeam0538911772072024-09-10
00053891177221Sunbeam0538911772212024-09-10
00053891177245Sunbeam0538911772452024-09-10
30053891177185Sunbeam0538911771842024-09-10
30053891177208Sunbeam0538911772072024-09-10
30053891177222Sunbeam0538911772212024-09-10
30053891177246Sunbeam0538911772452024-09-10
00053891172073Sunbeam0538911720732023-10-12
30053891172074Sunbeam0538911720732023-10-12
00053891162692Sunbeam0538911626922023-04-12
30053891162693Sunbeam0538911626922023-04-12
00053891172066Sunbeam0538911720662023-03-13
30053891172067Sunbeam0538911720662023-03-13
00053891172172Sunbeam0538911721722022-11-15
00053891172189Sunbeam0538911721892022-11-15
00053891174015Sunbeam0538911740152022-11-15

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