Oxygen Concentrator

Basic Information

• Brand Name: Oxygen Concentrator
• Primary DI: 00616784080017
• Version / Model: 10800
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-20
• Public Version: 1
• Public Version Date: 2019-08-28
• Public Version Status: New
• Public Device Record Key: 563178c1-154e-4677-a34f-f7efdadfdf49

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
CAW	Generator, Oxygen, Portable	Anesthesiology	868.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12873	Stationary oxygen concentrator	A stationary mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is typically wheeled but is designed to be placed in one location, e.g., an institution or a home setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00616784080017	GS1

Premarket Submissions

Submission Number	Supplement Number
K131968	000