Shiley

Basic Information

• Brand Name: Shiley
• Primary DI: 30884522006709
• Version / Model: 8PERC
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-31
• Public Version: 8
• Public Version Date: 2022-07-13
• Public Version Status: Update
• Public Device Record Key: f6f8853f-fcd0-4a00-b3b9-0b17df95959a
• Distribution End Date: 2022-05-04

Device Description

Percutaneous Tracheostomy Tube with Disposable Inner Cannula

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTO	Tube, tracheostomy (w/wo connector)	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35404	Tracheostomy tube, non-reinforced, non-customized, single-use	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 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 typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50884522006703	GS1	CASE	108	Not in Commercial Distribution	2022-05-04
Primary	30884522006709	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K884730	000

Device Sizes

Type	Value	Unit	Text
Length	79	Millimeter
Device Size Text, specify			Inner Diameter, 7.6, mm; Outer Diameter, 12.2, mm; Cuff Resting Diameter, 27.2, mm;

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 120 Degrees Fahrenheit