SHIELDMATE

Basic Information

• Brand Name: SHIELDMATE
• Primary DI: 10817583020557
• Version / Model: SHI SM 2005X
• Catalog Number: SHI SM 2005X
• Company Name: ALPHA PRO TECH INC
• Labeler DUNS: 003687733
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-11-03
• Public Version: 5
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: cfd2af72-45af-48ad-91c8-eaeb404c7a3c

Device Description

EARLOOP MASK W/EXTENDED SHIELD, BLUE 5 MIL.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• 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
FXX	Mask, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58376	Eye splash shield, single-use	A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817583020554	GS1	CASE	4	In Commercial Distribution
Primary	10817583020557	GS1
Unit of Use	00817583020550	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K882028	000