AccessGUDID - DEVICE: WYZ Face Mask (00860004437864)

GUDID

Device Identifier (DI) Information

Brand Name: WYZ Face Mask
Version or Model: 2111
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Wyz Medical Supplies LLC

Primary DI Number: 00860004437864
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 50
Labeler D-U-N-S® Number*: 117528113 *Terms of Use

Device Description: ASTM LEVEL 1 FACE MASK BLUE

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?
66199	Surgical/medical face mask, non-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 does not include an antimicrobial/antiviral agent(s) 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
LYU	Accessory, Surgical Apparel

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
Handling Environment Temperature: less than 104 Degrees Fahrenheit
Handling Environment Temperature: less than 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0e6be19-3e72-403c-97d4-eb18c0aa809e
Public Version Date: May 12, 2023
Public Version Number: 2
DI Record Publish Date: January 18, 2021