PM Excellence SEQUR 100

Primary DI
10850037258083
Brand
PM Excellence SEQUR 100
Company
PM EXCELLENCE LLC DOO BEOGRAD
Model
100
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.
Published
2023-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220520000PM Excellence SEQUR 100 Surgical Face MaskPm Excellence, LLC2022-12-15FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850037258083PrimaryGS10
00850037258086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003725808310850037258083
00850037258086008500372580868500372580860850037258086

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, antimicrobial, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
680785621
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
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10304040168612CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168629CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168643CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168650CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168926CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168933CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168940CriterionHENRY SCHEIN, INC.FXX2023-06-26
10087701434423Good NeighborShepard Medical Products, Inc.FXX2023-01-06
10096295122296LeaderShepard Medical Products, Inc.FXX2023-01-06
10096295137382LeaderShepard Medical Products, Inc.FXX2023-01-06