Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10884389148020
• Version / Model: BIOM2001A
• Catalog Number: BIOM2001A
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 5
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 378a5d44-f167-4e7d-9e3e-f85aba8d3f56

Device Description

BIOMASK,ANTIVIRAL, EARLOOP, BLUE, LF

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FXX	Mask, surgical	General, Plastic Surgery	878.4040	2
OUK	Surgical mask with antimicrobial/antiviral agent	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57792	Surgical/medical respirator, antimicrobial	A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large and small particles during medical, surgical, dental, and isolation procedures; it includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. It is designed to create an airtight seal against the user’s face and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40884389148021	GS1		6	In Commercial Distribution
Primary	10884389148020	GS1
Unit of Use	20884389148027	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry.