FDA.reportPublic FDA data

I-RELIEF Hot and Cold Therapy Eye Mask

Primary DI
00622554008907
Brand
I-RELIEF Hot and Cold Therapy Eye Mask
Company
I-Med Pharma Inc
Model
0890
Catalog number
0890
Device description
Hot & Cold Therapy Eye Mask with ThermaBeadsTM for therelief of symptoms associated with Blepharitis, Dry Eye Disease, MeibomianGland Disease (MGD), Styes and Chalazia as well as headaches, sinuspressure, tension, swelling and puffiness.
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMEPack, hot or cold, reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00622554008907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00622554008907006225540089076225540089070622554008907

GMDN Terms#

Term, Definition table
TermDefinition
Eye heat therapy pack, reusableA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(514)758-9998ilan@imedpharma.com

Regulatory Flags#

DUNS number
249008772
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00622554050005I-MED Nitrile Powder-Free and Latex-Free Gloves500050002020-06-18
00622554051002I-MED Surgical Mask510051002020-06-18
00622554052009I-MED KN95 Respirator Mask520052002020-06-18
00622554053006I-MED Single Use Face Mask530053002020-06-18
00622554054003I-MED Protective Facshield540054002020-07-07
00622554055000I-MED Protective Isolation Gown550055002020-06-18
00622554050012I-MED Nitrile Powder-Free and Latex-Free Gloves500050002020-06-18
00622554055017I-MED Surgical Mask510051002020-06-18
00622554052016I-MED KN95 Respirator Mask520052002020-06-18
00622554051019I-MED Protective Isolation Gown550055002020-06-18
00622554057004I-MED Non-Contact Infrared digital Clinical Thermometer570057002020-06-18
00622554054010I-MED Protective Facshield540054002020-07-07

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