I-RELIEF Hot and Cold Therapy Eye Mask

Basic Information

• Brand Name: I-RELIEF Hot and Cold Therapy Eye Mask
• Primary DI: 00622554008907
• Version / Model: 0890
• Catalog Number: 0890
• Company Name: I-Med Pharma Inc
• Labeler DUNS: 249008772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-18
• Public Version: 3
• Public Version Date: 2022-10-05
• Public Version Status: Update
• Public Device Record Key: d5aca48e-2e10-4d29-b9f6-25f093c551e4

Device Description

Hot & Cold Therapy Eye Mask with ThermaBeadsTM for the relief of symptoms associated with Blepharitis, Dry Eye Disease, Meibomian Gland Disease (MGD), Styes and Chalazia as well as headaches, sinus pressure, tension, swelling and puffiness.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• 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
IME	Pack, hot or cold, reusable	Physical Medicine	890.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61023	Eye heat therapy pack, reusable	A device intended to be placed over closed eyes to apply heat/steam 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 heat-retaining substance intended to be heated in a microwave oven prior to use; or 2) includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00622554008907	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]