AccessGUDID - DEVICE: Copioumed (04719882250255)

GUDID

Device Identifier (DI) Information

Brand Name: Copioumed
Version or Model: MS021P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COPIOUMED INTERNATIONAL INC.

Primary DI Number: 04719882250255
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 658318113 *Terms of Use

Device Description: Copioumed Medical Mask is a disposable device intended to cover the mouth and nose of the user to contain that user’s respiratory secretions, it provides a barrier to reduce the risk of spread of infective agents between staff and patient and protect patient during surgical procedures and other medical settings. This device is non-sterile and for single use only.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
66197	Surgical/medical face mask, antimicrobial, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It includes an antimicrobial/antiviral agent to prevent/inhibit the proliferation of microbes under specified conditions and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXX	Mask, Surgical

FDA Premarket Submission

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

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: c179c1e3-8e7f-49b0-87a4-7cc95085ee09
Public Version Date: August 30, 2022
Public Version Number: 1
DI Record Publish Date: August 22, 2022