Resp-O2 Oral Airways, Berman Type

Basic Information

• Brand Name: Resp-O2 Oral Airways, Berman Type
• Primary DI: 00840117316010
• Version / Model: 36312
• Company Name: Dynarex Corporation
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-22
• Public Version: 4
• Public Version Date: 2025-05-22
• Public Version Status: Update
• Public Device Record Key: 9ed3de60-5563-4f10-8a19-cad5a2202549

Device Description

Each Kit Contains: 1-Infant (40 mm), 1-Child (60 mm),1-Small Adult (80 mm),1-Medium Adult (90 mm),1-Large Adult (100 mm),1-XL Adult (110 mm)

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: No
• Has Expiration Date: No
• 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	00840117315884	GS1	Box	6	In Commercial Distribution
Primary	00840117316010	GS1
Package	00840117336216	GS1	Shipper	20	In Commercial Distribution