Resp-O2 Oral Airway, Berman Type

Basic Information

• Brand Name: Resp-O2 Oral Airway, Berman Type
• Primary DI: 00840117315969
• Version / Model: 36307
• 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: 1
• Public Version Date: 2021-04-30
• Public Version Status: New
• Public Device Record Key: 0a7c51ba-9103-40c5-8c27-be943a7a097a

Device Description

Resp-O2 Oral Airway, Berman Type, 90mm, Medium, 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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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	00840117315839	GS1	Inner Box	24	In Commercial Distribution
Primary	00840117315969	GS1