AccessGUDID - DEVICE: Copioumed (14719882250887)

GUDID

Device Identifier (DI) Information

Brand Name: Copioumed
Version or Model: EGN0B101-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COPIOUMED INTERNATIONAL INC.

Primary DI Number: 14719882250887
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 658318113 *Terms of Use

Device Description: Copioumed's Examination gown is a device for medical purposes, made of SMS material, that is draped or worn by the patient as a body covering during medical examinations. Provides patient protection from contamination by microorganisms, body fluids and particles.

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?
32170	Professional examination gown, single-use	A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FME	Gown, Examination

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 5e362c89-6dd5-4474-b83b-ccfe9896d079
Public Version Date: September 14, 2022
Public Version Number: 1
DI Record Publish Date: September 06, 2022