FDA.reportPublic FDA data

Copioumed

Primary DI
04719882251733
Brand
Copioumed
Company
COPIOUMED INTERNATIONAL INC.
Model
CTN3B302-1
Device description
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only.
Published
2025-07-16
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
FYCGown, Isolation, Surgical
QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYCGown, Isolation, SurgicalGeneral, Plastic Surgery2
QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy DrugsGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230135000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230135000Copioumed Chemotherapy Isolation GownCopioumed International, Inc.2023-10-04FYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719882251730PackageGS110In Commercial Distribution
04719882251733PrimaryGS10
04719882251726Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988225173014719882251730
04719882251733047198822517334719882251733
04719882251726047198822517264719882251726

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
658318113
Device count
10
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
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
14719882251716CopioumedCTN3B301-12025-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813360021475ProtexerICP MEDICAL, LLCFYC2025-08-15
10813360021472ProtexerICP MEDICAL, LLCFYC2025-08-15
00813360021468ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162000030ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162290004ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162390506ProtexerICP MEDICAL, LLCFYC2025-08-08
10813360021465ProtexerICP MEDICAL, LLCFYC2025-08-08
00813360021772ProtexerICP MEDICAL, LLCFYC2025-08-08
00842942015175PRIMEDpriMED Medical Products IncFYC2025-07-21
00842942015304PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015172PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015301PRIMEDpriMED Medical Products IncFYC2025-07-21
04719882251399CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251399CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251412CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251412CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251436CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251436CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251450CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251450CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251559CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251559CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251573CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251573CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251597CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251597CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251610CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251610CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251719CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251719CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16