FDA.reportPublic FDA data

I-MED Single Use Face Mask

Primary DI
00622554053006
Brand
I-MED Single Use Face Mask
Company
I-Med Pharma Inc
Model
5300
Catalog number
5300
Device description
Single-use face shield is intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer
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
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
QLADecontamination systems for facemasks, surgical masks, face shields, and safety glasses
QLBDecontamination systems for gloves, gowns, and other apparel excluding masks, respirators, face shields, safety goggles

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1
QLADecontamination systems for facemasks, surgical masks, face shields, and safety glasses
QLBDecontamination systems for gloves, gowns, and other apparel excluding masks, respirators, face shields, safety goggles

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00622554053006PrimaryGS10
00622554054010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00622554053006006225540530066225540530060622554053006
00622554054010006225540540106225540540100622554054010

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
249008772
Device count
110
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
00622554008907I-RELIEF Hot and Cold Therapy Eye Mask089008902020-06-18
00622554050005I-MED Nitrile Powder-Free and Latex-Free Gloves500050002020-06-18
00622554051002I-MED Surgical Mask510051002020-06-18
00622554052009I-MED KN95 Respirator Mask520052002020-06-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770535583Bausch + LombBausch & Lomb IncorporatedHOY2026-04-30
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2026-04-10
10620974004285BetterShieldSouthmedic IncorporatedHOY2025-12-19
D2481009320"""Heidi"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009330"""Ella"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009350"""Lucy"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
10827989003504Health Care Logistics, Inc®Health Care Logistics, Inc.HOY2025-01-08
TQ26126151971Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.HOY2024-12-09
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
00194613017101MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613028190MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613002770MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-04-25
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08052276029638Eye Shield AKTIVE SRLHOY2024-01-15
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