I-MED Protective Facshield

Basic Information

• Brand Name: I-MED Protective Facshield
• Primary DI: 00622554054003
• Version / Model: 5400
• Catalog Number: 5400
• Company Name: I-Med Pharma Inc
• Labeler DUNS: 249008772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 110
• Record Status: Published
• Publish Date: 2020-07-07
• Public Version: 2
• Public Version Date: 2022-10-05
• Public Version Status: Update
• Public Device Record Key: 5b893577-0689-4741-ae06-7f6f84ad159a

Device Description

The I-MED Protective Faceshield is a one-time-use face protection shield. It protects against splatter and airborne particles with a wrap-around face shield that is suitable for procedures demanding an increased level of protection.

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: No
• 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

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	00622554054003	GS1

Customer Contacts

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