Shiley

Basic Information

• Brand Name: Shiley
• Primary DI: 10884521177161
• Version / Model: 4.0NEF-P
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-11
• Public Version: 3
• Public Version Date: 2023-01-30
• Public Version Status: Update
• Public Device Record Key: 7b7131aa-7d38-4865-8721-6d795113f393
• Distribution End Date: 2021-09-11

Device Description

Neonatal Tracheostomy Tube Cuffless Disposable, Bedside Tray

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 Safe
• 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	20884521177168	GS1	CASE	24	Not in Commercial Distribution	2021-09-11
Primary	10884521177161	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K182861	000

Device Sizes

Type	Value	Unit	Text
Angle	120	degree
Outer Diameter	4	Millimeter
Device Size Text, specify			Size A, 11.1, MM; Size B, 0, MM; Size C, 22.9, MM;
Outer Diameter	6	Millimeter
Length	34	Millimeter