Shiley

Basic Information

• Brand Name: Shiley
• Primary DI: 40884521105554
• Version / Model: 5-18537
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-22
• Public Version: 6
• Public Version Date: 2023-03-31
• Public Version Status: Update
• Public Device Record Key: 1c629ec3-95e4-4226-ae3d-17f235d5c1a6

Device Description

Esophageal Tracheal Airway with X-Ray Line,Double Lumen. Manufactured under license of Frass and Frenzer.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAO	AIRWAY, ESOPHAGEAL (OBTURATOR)	Anesthesiology	868.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42420	Oesophageal-obturating/tracheal airway, single-use	A two-lumen, semiflexible, single-use tube inserted blindly through the mouth into the oesophagus or trachea to maintain airway patency while obturating the oesophagus, typically during emergencies to facilitate breathing/resuscitation. The oesophageal-obturating lumen has a blocked distal end and perforations at the pharyngeal level. A large oropharyngeal balloon seals mouth and nose; a distal cuff seals either the oesophagus or the trachea. Ventilation starts via the oesophageal tube, if the tube is in the oesophagus air enters the pharynx via the perforations; when the tube is in the trachea the ventilation is performed directly through the tracheal tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30884521103621	GS1	CASE	4	In Commercial Distribution
Primary	40884521105554	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K875226	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	37	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No UV
• Type: Storage Environment Temperature
• Temperature Range: 32 – 90 Degrees Fahrenheit