I-GEL, MEDIUM ADULT, SUPRAGLOTTIC AIRWAY, SIZE 4 (50-90KG)

Basic Information

• Brand Name: I-GEL, MEDIUM ADULT, SUPRAGLOTTIC AIRWAY, SIZE 4 (50-90KG)
• Primary DI: 05030267073696
• Version / Model: 8204000
• Company Name: Intersurgical Incorporated
• Labeler DUNS: 785952607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-19
• Public Version: 2
• Public Version Date: 2022-02-07
• Public Version Status: Update
• Public Device Record Key: e6f01dc7-de04-436d-9ce6-1bd141048286

Device Description

I-GEL, MEDIUM ADULT, SUPRAGLOTTIC AIRWAY, SIZE 4 (50-90KG)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• 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	05030267043392	GS1		25	In Commercial Distribution
Primary	05030267073696	GS1

Customer Contacts

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