Resp-O2 Venturi Mask

Basic Information

• Brand Name: Resp-O2 Venturi Mask
• Primary DI: 00840117310797
• Version / Model: 33070
• 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: 915defa9-c9f1-4e22-abc0-913528aaa6ae

Device Description

Resp-O2 Venturi Select A Vent Elongated Adult Mask w/ 6 Dilutors, 7' (2.1m) Crush Resistant Tubing, Standard Connector

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
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	868.5600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35175	Venturi oxygen face mask	A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840117310803	GS1	Case	50	In Commercial Distribution
Primary	00840117310797	GS1