AccessGUDID - DEVICE: AMERICANA DISPOSABLE FACE MASK (08936081250237)

GUDID

Device Identifier (DI) Information

Brand Name: AMERICANA DISPOSABLE FACE MASK
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WAKAMONO CORPORATION

Primary DI Number: 08936081250237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 555536276 *Terms of Use

Device Description: Non-fiberglass, non-irritation, non-carcinogen (formaldehyde) Waterproof, airy, non-irritating fabrics Easily adjusted nose clip helps fixed and best fit to face Reliable and elastic earloops for comfortable use.

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?
64821	Public face mask, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; 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). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKR	Face Mask (Except N95 Respirator) For General Public/Healthcare Personnel Per Iie Guidance

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: 53fce67a-8a4c-4b5e-8f8d-3dd9be02b935
Public Version Date: September 24, 2020
Public Version Number: 1
DI Record Publish Date: September 16, 2020