PT

Basic Information

• Brand Name: PT
• Primary DI: 28938533047055
• Version / Model: PT05
• Company Name: PHU TUONG GARMENT COMPANY LIMITED
• Labeler DUNS: 556034954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-09-08
• Public Version: 1
• Public Version Date: 2020-09-16
• Public Version Status: New
• Public Device Record Key: 67995f83-556c-4939-989c-ef24731c6006

Device Description

Face mask is made of fabric material, either non-woven or woven

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QKR	Face Mask (Except N95 Respirator) For General Public/Healthcare Personnel Per Iie Guidance	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	28938533047055	GS1
Unit of Use	18938533047058	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius