N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00607411007446
• Version / Model: TP100-0-25
• Catalog Number: TP100-0-25
• Company Name: SALTER LABS
• Labeler DUNS: 022721133
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-06-11
• Public Version Status: Update
• Public Device Record Key: 83fef3bc-c633-41cc-b18b-dfce4fae4b6b

Device Description

Tilson Trach Guard

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
BZA	CONNECTOR, AIRWAY (EXTENSION)	Anesthesiology	868.5810	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
Primary	00607411007446	GS1

Customer Contacts

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