Shiley

Basic Information

• Brand Name: Shiley
• Primary DI: 10884521555075
• Version / Model: M10LGT
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-23
• Public Version: 7
• Public Version Date: 2024-03-01
• Public Version Status: Update
• Public Device Record Key: 8fc19896-e009-41b4-b96d-e16aafc995c5

Device Description

Specialized Laryngectomy Tube

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: 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
12292	Laryngectomy tube	A hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved/contoured tube, similar to a tracheostomy tube, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	90884521555071	GS1	CASE	99	In Commercial Distribution
Primary	10884521555075	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K962173	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Inner Diameter, 8.9, MM; Outer Diameter, 13.7, MM;

Storage Conditions

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