I-MED Single Use Face Mask

Basic Information

• Brand Name: I-MED Single Use Face Mask
• Primary DI: 00622554053006
• Version / Model: 5300
• Catalog Number: 5300
• Company Name: I-Med Pharma Inc
• Labeler DUNS: 249008772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 110
• Record Status: Published
• Publish Date: 2020-06-18
• Public Version: 2
• Public Version Date: 2022-10-05
• Public Version Status: Update
• Public Device Record Key: de2ba942-101d-48d3-9669-94162f103b4b

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

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: No
• 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
HOY	Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)	Ophthalmic	886.4750	1
QLA	Decontamination systems for facemasks, surgical masks, face shields, and safety glasses
QLB	Decontamination systems for gloves, gowns, and other apparel excluding masks, respirators, face shields, safety goggles

GMDN Terms

Code	Name	Definition	Implantable	Status
11961	Face splash shield, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00622554054010	GS1
Primary	00622554053006	GS1

Customer Contacts

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