RUSCH

Basic Information

• Brand Name: RUSCH
• Primary DI: 04026704010431
• Version / Model: IPN041805
• Catalog Number: 120101-000100
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 5
• Public Version Date: 2023-02-24
• Public Version Status: Update
• Public Device Record Key: 77011c6f-166d-4b8c-9b98-0f7b2e6b0644

Device Description

Tracheostomy tube set, short, phonation

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOH	Tube tracheostomy and tube cuff	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38792	Tracheostomy tube, non-reinforced, non-customized, reusable	A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704010435	GS1	Box	2	In Commercial Distribution
Primary	04026704010431	GS1
Package	44026704010439	GS1	Carton	28	Not in Commercial Distribution	2023-02-22

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K964056	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	13.4	Millimeter
Lumen/Inner Diameter	10	Millimeter
Device Size Text, specify			I.D. 10.0

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight; Keep dry