ProGear

Basic Information

• Brand Name: ProGear
• Primary DI: 00852212003504
• Version / Model: FM89011
• Company Name: PRESTIGE AMERITECH, LTD.
• Labeler DUNS: 199692794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2019-09-17
• Public Version: 2
• Public Version Date: 2020-04-06
• Public Version Status: Update
• Public Device Record Key: aba68189-7b44-44e1-8ad3-ec10f3649adb

Device Description

Face Shield with Headlight Flap, Foam Top, Elastic Headband

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: No
• 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: No
• 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
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	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
Package	10852212003501	GS1	Case	4	In Commercial Distribution
Primary	00852212003504	GS1
Unit of Use	80852212003500	GS1

Customer Contacts

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