GOBEN

Basic Information

• Brand Name: GOBEN
• Primary DI: 06979032640055
• Version / Model: JD14-R430106
• Company Name: HUZHOU JUNDA INDUSTRY CO., LTD.
• Labeler DUNS: 452976115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-26
• Public Version: 1
• Public Version Date: 2025-09-03
• Public Version Status: New
• Public Device Record Key: 76e93f80-1445-4054-9e67-530d4190509b

Device Description

Guedel Airway - 90 mm Disposable Yellow

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTQ	Airway, Nasopharyngeal	Anesthesiology	868.5100	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
Primary	06979032640055	GS1
Package	16979032640052	GS1	box	50	In Commercial Distribution
Package	26979032640059	GS1	carton	250	In Commercial Distribution