FDA.reportPublic FDA data

Copioumed

Primary DI
04719882252945
Brand
Copioumed
Company
Copious International Inc.
Model
MS032BL
Device description
Copioumed The mask is made of melt-blown non-woven fabric for medical personnel to wear during invasive operation, covering the user's mouth, nose and jaw to provide a physical barrier to prevent pathogens, microorganisms, body fluids, particles, etc.
Published
2023-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719882252942PackageGS112In Commercial Distribution
04719882252945PrimaryGS10
04719882252938Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988225294214719882252942
04719882252945047198822529454719882252945
04719882252938047198822529384719882252938

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.

Contacts#

Phone, Email table
PhoneEmail
+886227721815info@gcv.com.tw

Regulatory Flags#

DUNS number
527237481
Device count
50
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719882252761Copioumed MS031W2023-08-25
04719882252785CopioumedMS031B2023-08-25
04719882252808Copioumed MS031G2023-08-25
04719882252822CopioumedMS031P2023-08-25
04719882252846CopioumedMS031BL2023-08-25
04719882252860CopioumedMS032W2023-08-25
04719882252884CopioumedMS032B2023-08-25
04719882252907CopioumedMS032G2023-08-25
04719882252921CopioumedMS032P2023-08-25
04719882252969CopioumedMS041W2023-08-25
04719882252983CopioumedMS041B2023-08-25
04719882253003CopioumedMS041G2023-08-25
04719882253027CopioumedMS041P2023-08-25
04719882253041CopioumedMS041BL2023-08-25
04719882253065CopioumedMS042W2023-08-25
04719882253089CopioumedMS042B2023-08-25
04719882253102CopioumedMS042G2023-08-25
04719882253126CopioumedMS042P2023-08-25
04719882253140CopioumedMS042BL2023-08-25
04719882253164CopioumedSHN0W111-12023-08-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03
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16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
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