PULSE QUALITY MASK

Basic Information

• Brand Name: PULSE QUALITY MASK
• Primary DI: 00860004103318
• Version / Model: 1
• Company Name: IMPULSE FASHION VIETNAM GARMENT EXPORTING LIMITED COMPANY
• Labeler DUNS: 557264015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-06-26
• Public Version: 1
• Public Version Date: 2020-07-06
• Public Version Status: New
• Public Device Record Key: 6da8fe9e-d191-4732-b6cd-85cc7bd87eac

Device Description

Fabric mask washable up to 30x times Water Resistant Soft and Breathable Tripple Layer Protection

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64822	Public face mask, reusable	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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	08600041033184	GS1
Primary	00860004103318	GS1