ProCure

Basic Information

• Brand Name: ProCure
• Primary DI: 10840330703410
• Version / Model: 1005620
• Catalog Number: 1005620
• Company Name: Twin Med, LLC
• Labeler DUNS: 107071289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-02-23
• Public Version: 2
• Public Version Date: 2026-04-09
• Public Version Status: Update
• Public Device Record Key: 6d034008-450a-49a1-84ae-0380e14f394c

Device Description

Tracheostomy Trach Tube Holder, Extra Wide, 2 Piece, L 17" x 1 3/8"

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: 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
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	00840330703413	GS1
Primary	10840330703410	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	17.5	Inch
Width	1.375	Inch