PM Excellence SEQUR 100

Basic Information

• Brand Name: PM Excellence SEQUR 100
• Primary DI: 10850037258083
• Version / Model: 100
• Company Name: PM EXCELLENCE LLC DOO BEOGRAD
• Labeler DUNS: 680785621
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-02-27
• Public Version: 1
• Public Version Date: 2023-03-07
• Public Version Status: New
• Public Device Record Key: e7884855-4fc9-4121-a622-7ba2da27043e

Device Description

PM Excellence SEQUR 100 is a flat pleated, 3-layer surgical face mask with non-latex elastic ear loops and malleable nose wire piece. Product Characteristics: • Three layers of breathable non-woven polypropylene fabric • Integrated shapeable nose wire for better fit • Non latex elastic ear loops for greater comfort • Non-cytotoxic, non-irritating and non-sensitizing • Single use, disposable, non-sterile • Provides full coverage, starting from the malleable component of the nose piece at the top all the way to the snug, yet comfortable fit under the chin.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
66197	Surgical/medical face mask, antimicrobial, 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). It includes an antimicrobial/antiviral agent to prevent/inhibit the proliferation of microbes under specified conditions and 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. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850037258083	GS1
Unit of Use	00850037258086	GS1

Premarket Submissions

Submission Number	Supplement Number
K220520	000