Big Mouth™ Oral Airway with Balloon

Basic Information

• Brand Name: Big Mouth™ Oral Airway with Balloon
• Primary DI: 00850027063010
• Version / Model: OA4100
• Catalog Number: OA4100
• Company Name: Wm & Dg, Inc.
• Labeler DUNS: 117870208
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-23
• Public Version: 1
• Public Version Date: 2023-03-03
• Public Version Status: New
• Public Device Record Key: 2d3a4076-252c-47dd-abc0-bc52bac88e48

Device Description

The Big Mouth™ Oral Airway with Balloon is a single-use, non-sterile, 2-lumen channel, flexible device intended to be used for maintaining an open airway and facilitating intubation in airway management for adults > 55kg (121 lbs.)

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: 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: Yes
• 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
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	868.5110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42424	Oropharyngeal airway, single-use	A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850027063017	GS1	Box	130	In Commercial Distribution
Primary	00850027063010	GS1
Package	20850027063014	GS1	Carton	4	In Commercial Distribution