FDA.report

Sunbeam

Primary DI
20053891128425
Brand
Sunbeam
Company
Jarden Consumer Solutions
Model
053891128421
Device description
HLMS WHOLE HOUSE CONSOLE HUMDIFIER
Published
2019-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
20053891128425PackageGS11In Commercial Distribution
00053891128421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2005389112842520053891128425
00053891128421000538911284210538911284210053891128421

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

Regulatory Flags

DUNS number
001315134
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00053891181952Sunbeam0538911819522025-12-03
30053891177185Sunbeam0538911771842024-09-10
30053891177208Sunbeam0538911772072024-09-10
30053891177222Sunbeam0538911772212024-09-10
30053891177246Sunbeam0538911772452024-09-10
30053891172074Sunbeam0538911720732023-10-12
30053891162693Sunbeam0538911626922023-04-12
30053891172067Sunbeam0538911720662023-03-13
30053891172173Sunbeam0538911721722022-11-15
30053891172180Sunbeam0538911721892022-11-15
30053891174016Sunbeam0538911740152022-11-15
30053891174023Sunbeam0538911740222022-11-15
30053891165960Sunbeam0538911659692022-04-12
30053891165021Sunbeam0538911650202021-12-07
30053891160507Sunbeam0538911605062021-06-22
30053891162808Sunbeam0538911628072021-05-26
30053891162815Sunbeam0538911628142021-05-26
30053891162822Sunbeam0538911628212021-05-26
30053891162839Sunbeam0538911628382021-05-26
30053891162846Sunbeam0538911628452021-05-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00194346604845EquateWAL-MART STORES, INC.KFZ2026-02-16
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
10050428005603CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-26
10050428005610CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKFZ2026-01-23
20889483054335AirLife™SUNMED, LLCKFZ2025-12-19
20889483229429AirLife™SUNMED, LLCKFZ2025-12-19
20889483054328AirLife™SUNMED, LLCKFZ2025-12-18
00328785012415VicksKAZ USA, INC.KFZ2025-12-16
00328785014402VicksKAZ USA, INC.KFZ2025-12-16
00328785014440VicksKAZ USA, INC.KFZ2025-12-16
00328785014464VicksKAZ USA, INC.KFZ2025-12-16
10889483221891AirLife™SUNMED, LLCKFZ2025-12-16
10889483221907AirLife™SUNMED, LLCKFZ2025-12-16
00810115635185Pure EnrichmentBEAR DOWN CONSULTINGKFZ2025-09-08
10328785002451VicksKAZ, INC.KFZ2025-05-05
10328785002475VicksKAZ, INC.KFZ2025-05-05
00328785012019VicksKAZ USA, INC.KFZ2025-05-05
00328785012378VICKSKAZ USA, INC.KFZ2025-05-05