TRACHEOSTOMY and SUCTION ACCESSORY

Basic Information

• Brand Name: TRACHEOSTOMY and SUCTION ACCESSORY
• Primary DI: 00848530094881
• Version / Model: AOP601GS
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-28
• Public Version: 1
• Public Version Date: 2025-09-05
• Public Version Status: New
• Public Device Record Key: 12395717-3644-4af7-bb34-e3e440bdaec2

Device Description

Sunset Oropharyngeal Airway, Guedel, Soft, 60mm, Size 1

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	10848530094888	GS1		30	In Commercial Distribution
Primary	00848530094881	GS1
Package	20848530094885	GS1		10	In Commercial Distribution