konsung

Basic Information

• Brand Name: konsung
• Primary DI: 06934822565031
• Version / Model: KSOC-5
• Company Name: Jiangsu Konsung Bio Medical Science and Technology Co., Ltd.
• Labeler DUNS: 544307339
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-26
• Public Version: 1
• Public Version Date: 2023-11-03
• Public Version Status: New
• Public Device Record Key: 303adb54-061a-4284-bfdd-33566c8f17e6

Device Description

The Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. The device can be used in home, institution environments. The device is not intended to sustain or support life. The device is intended for use in adults.

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: Yes
• 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	06934822565031	GS1

Premarket Submissions

Submission Number	Supplement Number
K223740	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 93 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal