Mabis

Basic Information

• Brand Name: Mabis
• Primary DI: 00767056181212
• Version / Model: 40-742-000
• Company Name: D-M-S HOLDINGS, INC.
• Labeler DUNS: 062028220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-03
• Public Version: 1
• Public Version Date: 2024-01-11
• Public Version Status: New
• Public Device Record Key: dfc1f5e6-4376-44ee-8edf-55285ccb4035

Device Description

Steam Inhaler w/Facial Mask

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	868.5460	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63562	Home-use facial steamer	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10767056181219	GS1	Master carton	6	In Commercial Distribution
Primary	00767056181212	GS1