Trach Tie

Basic Information

• Brand Name: Trach Tie
• Primary DI: 00850014574383
• Version / Model: 540W
• Catalog Number: 540W
• Company Name: PEPPER MEDICAL INC.
• Labeler DUNS: 622637098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-04-17
• Public Version: 2
• Public Version Date: 2023-11-08
• Public Version Status: Update
• Public Device Record Key: 66adeb37-0f86-43b0-a3d6-3518d4032d01

Device Description

Adult Trach Tube Holder

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: Yes
• MRI Safety: MR Safe
• 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
63438	Tracheostomy tube neck holder, single-use	A non-sterile, 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10850014574380	GS1
Primary	00850014574383	GS1

Customer Contacts

• Phone: [phone] ext. 2
• Email: [email protected]