FDA.reportPublic FDA data

Copioumed

Primary DI
04719882253324
Brand
Copioumed
Company
Copious International Inc.
Model
IGN0Y1083-1
Device description
COPIOUMED Isolation gown is made of non-woven fabric and combined with materials with better permeability resistance as plastic film. It can cover the body and all clothing, forming a physical barrier to prevent the spread of substances such as microorganisms. To protect the safety of medical staff and avoid the secondary infection of patients.
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
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719882253321PackageGS15In Commercial Distribution
04719882253324PrimaryGS10
04719882253317Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988225332114719882253321
04719882253324047198822533244719882253324
04719882253317047198822533174719882253317

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Contacts#

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

Regulatory Flags#

DUNS number
527237481
Device count
10
Premarket exempt
true
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
04719882252945CopioumedMS032BL2023-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
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10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
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10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
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10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
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10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106829097CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106818862CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-05
10197106820759CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-29
10197106741979CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-11
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106796115CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106744192CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26