Shiley

Basic Information

• Brand Name: Shiley
• Primary DI: 10884521103481
• Version / Model: 4.0NCF
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-12
• Public Version: 5
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: 1f488265-498d-4dd6-8b93-f988e92a82c2

Device Description

Neonatal Tracheostomy Tube with TaperGuard Cuff

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
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	20884521103488	GS1	CASE	48	In Commercial Distribution
Primary	10884521103481	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K182861	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Inner Diameter, 4.0, mm; Outer Diameter, 6.0, mm; Cuff Resting Diameter, 11.5, mm; Size A, 11.1, mm; Size B, 0.0, mm; Size C, 22.9, mm; Angle, 120, Degrees;
Length	34	Millimeter
Outer Diameter	4.0	Millimeter

Storage Conditions

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