Shiley

Basic Information

• Brand Name: Shiley
• Primary DI: 10884521197589
• Version / Model: 33760
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-20
• Public Version: 4
• Public Version Date: 2022-12-14
• Public Version Status: Update
• Public Device Record Key: 449d127f-e5d5-4a16-957e-9e4feabc4289
• Distribution End Date: 2019-10-31

Device Description

Laryngeal Mask

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: Yes
• 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
CAE	AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY	Anesthesiology	868.5110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45036	Laryngeal mask airway, single-use	A curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521197586	GS1	PACK_OR_INNER_PACK	10	Not in Commercial Distribution	2019-10-31
Primary	10884521197589	GS1
Package	30884521197583	GS1	CASE	5	Not in Commercial Distribution	2019-10-31

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter
Device Size Text, specify			Size 6, 70-100 kg; Pressure, 60, cmH2O; Inside Diameter, 11.5, mm;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry;AVOID DIRECT SUNLIGHT