Trinity Sterile, Inc.

Basic Information

• Brand Name: Trinity Sterile, Inc.
• Primary DI: 10841767102876
• Version / Model: 20107
• Company Name: Trinity Sterile, Inc.
• Labeler DUNS: 154424043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-29
• Public Version: 2
• Public Version Date: 2023-10-31
• Public Version Status: Update
• Public Device Record Key: 65114c07-b0ac-4f72-a506-77f56428907f

Device Description

TRACH CARE W/SALINE/PERO

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXA	Tracheotomy care kit	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14090	Tracheostomy care kit, single-use	A collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00841767102879	GS1		20	In Commercial Distribution
Primary	10841767102876	GS1