FDA.reportPublic FDA data

Copioumed

Primary DI
14719882250870
Brand
Copioumed
Company
COPIOUMED INTERNATIONAL INC.
Model
SHN0W201-1
Device description
Copioumed’s Protective Shoe Cover is used by medical personnel in medical institutions to prevent contact with potentially infectious patient blood, body fluids, secretions, etc., and play a barrier and protection role.
Published
2022-09-06
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
FXPCover, Shoe, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719882250870PrimaryGS10
04719882250873Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988225087014719882250870
04719882250873047198822508734719882250873

GMDN Terms#

Term, Definition table
TermDefinition
Shoe coverA loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
658318113
Device count
200
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
04719882251399CopioumedCTN3B101-12025-07-16
04719882251412CopioumedCTN3B102-12025-07-16
04719882251436CopioumedCTN3B103-12025-07-16
04719882251450CopioumedCTN3B104-12025-07-16
04719882251559CopioumedCTN3B201-12025-07-16
04719882251573CopioumedCTN3B202-12025-07-16
04719882251597CopioumedCTN3B203-12025-07-16
04719882251610CopioumedCTN3B204-12025-07-16
04719882251719CopioumedCTN3B301-12025-07-16
04719882251733CopioumedCTN3B302-12025-07-16
04719882251757CopioumedCTN3B303-12025-07-16
04719882251771CopioumedCTN3B304-12025-07-16
14719882251396CopioumedCTN3B101-12025-07-16
14719882251419CopioumedCTN3B102-12025-07-16
14719882251433CopioumedCTN3B103-12025-07-16
14719882251457CopioumedCTN3B104-12025-07-16
14719882251556CopioumedCTN3B201-12025-07-16
14719882251570CopioumedCTN3B202-12025-07-16
14719882251594CopioumedCTN3B203-12025-07-16
14719882251617CopioumedCTN3B204-12025-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344164049MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-30
20197344133120MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
20197344151575MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
10197344103973MEDLINEMEDLINE INDUSTRIES, INC.FXP2025-04-05
10810141933214VIVIT SupplyVivit Supply LLCFXP2024-11-29
10810141933221VIVIT SupplyVivit Supply LLCFXP2024-11-29
10850053289504SURGYCOSurgyco LLCFXP2024-08-09
20197344036117MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344074454MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344036049MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344036056MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344029607MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-22
20197344029614MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-19
30080196745795MedlineMEDLINE INDUSTRIES, INC.FXP2023-10-12
10810141930435VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930442VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930626Vivit SupplyVivit Supply LLCFXP2023-09-15
10810141930633Vivit SupplyVivit Supply LLCFXP2023-09-15
10810141930923VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930930VIVIT SupplyVivit Supply LLCFXP2023-09-15
10097604459546Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28
10097604469750Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28
10849233004877Busse Hospital DisosablesROBERT BUSSE & CO., INC.FXP2023-06-16
10849233005003Busse Hospital DisposablesROBERT BUSSE & CO., INC.FXP2023-06-16
10097604470022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10097604472248Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10097604474754Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10850044799586SURGYCOSurgyco LLCFXP2023-02-16
20192253063322CARDINAL HEALTHCardinal Health 200, LLCFXP2023-01-13
10810087350175CoulmedCoulmed Products Group LLCFXP2023-01-06