Argyle

Basic Information

• Brand Name: Argyle
• Primary DI: 10192253044591
• Version / Model: 49000
• Catalog Number: 49000
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-26
• Public Version: 1
• Public Version Date: 2025-09-03
• Public Version Status: New
• Public Device Record Key: e7b9cae9-a61b-4f0a-b37c-c08f502d5183

Device Description

Argyle Tracheostomy Tube Holder Feature Benefit

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: Yes
• 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
CBH	Device, fixation, tracheal tube	Anesthesiology	868.5770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35752	Tracheostomy tube neck holder, reusable	A noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50192253044599	GS1	CASE	100	In Commercial Distribution
Primary	10192253044591	GS1