Medi Grade

Basic Information

• Brand Name: Medi Grade
• Primary DI: 06950396345435
• Version / Model: 185mm*80mm
• Company Name: Henan Chaoya Medical Equipment Co., Ltd.
• Labeler DUNS: 544573402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-28
• Public Version: 1
• Public Version Date: 2026-02-05
• Public Version Status: New
• Public Device Record Key: 8d9ee12d-42aa-459d-bee2-ea6e53102f1b

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMP	Pad, Eye	General, Plastic Surgery	878.4440	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65753	Eye hot/cold therapy mask, single-use	A non-powered device intended to be placed over closed eyes to apply heat/steam and/or cold to the eyes for the treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is typically in the form of a mask-shaped fabric envelope which either: 1) contains a thermal-insulating substance intended to be heated in a microwave oven or cooled in a freezer prior to use; or 2) includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated. Some types have a non-pharmaceutical antimicrobial coating to reduce eye infection risk. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06950396345435	GS1