FDA.reportPublic FDA data

Mabis

Primary DI
00767056181212
Brand
Mabis
Company
D-M-S HOLDINGS, INC.
Model
40-742-000
Device description
Steam Inhaler w/Facial Mask
Published
2024-01-03
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
10767056181219PackageGS16In Commercial Distribution
00767056181212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076705618121910767056181219
00767056181212007670561812127670561812120767056181212

GMDN Terms#

Term, Definition table
TermDefinition
Home-use facial steamerAn electrically-powered device designed to create steam for facial skin cleansing, typically by providing a cone-shaped applicator for channelling the steam to the face. It may also be used for clearing the nasal passages by inhalation of the steam. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.

Regulatory Flags#

DUNS number
062028220
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041298995326DMI619-5140-19002026-06-05
00767056160026MABIS01-160-02101-160-0212016-09-23
00767056160088MABIS01-160-08101-160-0812016-09-23
00767056160156MABIS01-160-15101-160-1512016-09-23
00767056160200MABIS01-160-20101-160-2012016-09-23
00767056160217MABIS01-160-21101-160-2112016-09-23
00767056160248MABIS01-160-24101-160-2412016-09-23
00767056410176MABIS09-141-01709-141-0172016-09-23
00767056110212MABIS01-110-02101-110-0212016-09-23
00767056234017MABIS05-234-01005-234-0102016-09-23
00767056300118MABIS01-130-01101-130-0112016-09-23
00767056300156MABIS01-130-01501-130-0152016-09-23
00767056300163MABIS01-130-01601-130-0162016-09-23
00767056322059MABIS05-223-06005-223-0602016-09-23
00767056400115MABIS01-140-01101-140-0112016-09-23
00767056400139MABIS01-140-01301-140-0132016-09-23
00767056400153MABIS01-140-01501-140-0152016-09-23
00767056400160MABIS01-140-01601-140-0162016-09-23
00767056400177MABIS01-140-01701-140-0172016-09-23
00767056550117MABIS01-155-01101-155-0112016-09-23

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