FACE MASKS

Basic Information

• Brand Name: FACE MASKS
• Primary DI: 08056646501441
• Version / Model: 30.M1221.00
• Company Name: OMNIA SRL
• Labeler DUNS: 447696675
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-08-30
• Public Version: 5
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 1ad56acd-aa1c-4729-af79-d720d6c900a9

Device Description

3-LAYER FACE MASK WITH SPLASHGUARD VISOR AND ELASTIC BANDS - LIGHT BLUE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
35177	Surgical/medical face mask, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056646501441	GS1
Unit of Use	08056646501434	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K911334	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP AWAY FROM SUNLIGHT AND KEEP DRY