Trinity Sterile, Inc.

Basic Information

• Brand Name: Trinity Sterile, Inc.
• Primary DI: 40841767106004
• Version / Model: 2267A
• Company Name: Trinity Sterile, Inc.
• Labeler DUNS: 154424043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-29
• Public Version: 1
• Public Version Date: 2023-09-06
• Public Version Status: New
• Public Device Record Key: e90e9f16-503f-4728-9cff-ef3b7b43fc96

Device Description

MASK EARLOOP BLUE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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
Package	00841767106006	GS1		1000	In Commercial Distribution
Primary	40841767106004	GS1