FDA.reportPublic FDA data

Copioumed

Primary DI
04719882250767
Brand
Copioumed
Company
COPIOUMED INTERNATIONAL INC.
Model
PGN0B101-1
Device description
Copioumed's patient gowns are protective clothing made for patients to protect patients from bacterial infections.
Published
2022-09-02
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
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719882250764PackageGS112In Commercial Distribution
04719882250767PrimaryGS10
04719882250750Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988225076414719882250764
04719882250767047198822507674719882250767
04719882250750047198822507504719882250750

GMDN Terms#

Term, Definition table
TermDefinition
Patient gown, single-useA non-sterile garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and may be closed by ties at the back/side of the garment. This is a single-use garment.

Contacts#

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

Regulatory Flags#

DUNS number
658318113
Device count
10
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
04719882251900CopioumedSGS3B102-12026-07-31
04719882251924CopioumedSGS3B103-12026-07-31
04719882251948CopioumedSGS3B104-12026-07-31
04719882251962CopioumedSGS3B201-12026-07-31
04719882251887CopioumedSGS3B101-12026-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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