AccessGUDID - DEVICE: Copioumed (04719882251610)

GUDID

Device Identifier (DI) Information

Brand Name: Copioumed
Version or Model: CTN3B204-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COPIOUMED INTERNATIONAL INC.

Primary DI Number: 04719882251610
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 658318113 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35492	Isolation gown, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYC	Gown, Isolation, Surgical
QSO	Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230135	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 42cac47b-83b4-43ae-8b39-af90bb5bdc19
Public Version Date: July 24, 2025
Public Version Number: 1
DI Record Publish Date: July 16, 2025