FDA.reportPublic FDA data

Premium Plus

Primary DI
D1252288MON2
Brand
Premium Plus
Company
Premium Plus (Dongguan) Limited
Model
2288MON
Catalog number
2288
Device description
Disposable Medical Face Masks (Ear Loop)
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D1252288MON8PackageHIBCC20In Commercial Distribution
D1252288MON2PrimaryHIBCC0
D1252288MON0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-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 does not include an antimicrobial/antiviral agent(s) 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.

Regulatory Flags#

DUNS number
541637603
Device count
50
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D1250802Premium Plus0802026-05-27
D1250812Premium Plus0812026-05-27
D1250822Premium Plus0822026-05-27
D1254104Premium Plus4102026-05-27
D1254114Premium Plus4112026-05-27
D1254124Premium Plus4122026-05-27
D1254134Premium Plus4132026-05-27
D1254144Premium Plus4142026-05-27
D1254154Premium Plus4152026-05-27
D1254164Premium Plus4162026-05-27
D1254174Premium Plus4172026-05-27
D1254184Premium Plus4182026-05-27
D1254194Premium Plus4192026-05-27
D1254204Premium Plus4202026-05-27
D1254304Premium Plus4302026-05-27
D125780MLB2Premium Plus780MLB2026-05-27
D125780MW2Premium Plus780MW2026-05-27
D125780SLB2Premium Plus780SLB2026-05-27
D125780SW2Premium Plus780SW2026-05-27
D125YS10012Premium PlusYS10012026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10097604956557Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
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10097604245064Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
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