NA

Basic Information

• Brand Name: NA
• Primary DI: 06938119388204
• Version / Model: Oropharyngeal airway(Model:8.0#)
• Company Name: Henan Tuoren Medical Device Co.,Ltd.
• Labeler DUNS: 526982680
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-19
• Public Version: 1
• Public Version Date: 2022-11-28
• Public Version Status: New
• Public Device Record Key: cd6ddd46-0ce7-4d25-8964-5f47ad0ca201

Device Description

Oropharyngeal airway(Model:8.0#)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
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	16938119388218	GS1	Middle Box	50	In Commercial Distribution
Primary	06938119388204	GS1
Package	26938119388222	GS1	Carton	4	In Commercial Distribution