Medex

Basic Information

• Brand Name: Medex
• Primary DI: 00788942275006
• Version / Model: 22-7500
• Company Name: SMITHS MEDICAL ASD, INC.
• Labeler DUNS: 828611934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-18
• Public Version: 2
• Public Version Date: 2020-09-14
• Public Version Status: Update
• Public Device Record Key: 60c9f992-fc57-4578-8b2d-016f2394585b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
ION	EXERCISER, NON-MEASURING	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43017	Respiratory muscle training mask	A mask placed over the nose/mouth designed to create resistance for a patient's airway while inhaling and/or exhaling during respirations to strengthen and rehabilitate the respiratory muscles. It typically creates resistance through a mechanical means (e.g., a spring-loaded valve) that can be adjusted to provide progressive training. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50788942275001	GS1	Case	10	In Commercial Distribution
Primary	00788942275006	GS1