One Piece Tracheostomy Tie Adult 2.5cm x 43cm (17in)

Basic Information

• Brand Name: One Piece Tracheostomy Tie Adult 2.5cm x 43cm (17in)
• Primary DI: 00848530103514
• Version / Model: RES029-17
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2024-03-20
• Public Version: 1
• Public Version Date: 2024-03-28
• Public Version Status: New
• Public Device Record Key: ae6c7f16-8e3d-4778-ba9b-5a08a3b86c08

Device Description

Adult One Piece Trach Ties, 2.5x43cm (17in) - 20/box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
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	10848530103511	GS1
Primary	00848530103514	GS1

Customer Contacts

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