konsung

FDA UDI

Class II (US FDA UDI)

by Jiangsu Konsung Bio Medical Science and Technology Co., Ltd.

Identity

Trade Name: konsung FDA UDI
Generic Name: Stationary oxygen concentrator FDA UDI
Device Name: 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. FDA UDI
Model / Reference: KSN-5 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 06934822565024 FDA UDI
510(k) Number: K223740 FDA UDI
FDA Product Code: CAW FDA UDI
GMDN Term: Stationary oxygen concentrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5440 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Stationary oxygen concentrator

konsung by Jiangsu Konsung Bio Medical Science and Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary oxygen concentrator.

MARK 5 NUVO LITE — Nidek Medical Products Inc. · Class II
NewLife Elite — Airsep Corp. · Class II
OxyHome — Mv Life LLC · Class II
NewLife Intensity 10 — CAIRE INC. · Class II
NewLife Intensity — Airsep Corp. · Class II
DeVilbiss — DeVilbiss Healthcare LLC. · Class II
Oxygen Concentrator — Proactive Medical Products · Class II
Inogen At Home Stationary Concentrator — Inogen, Inc. · Class II

Cleared under the same submission

K223740 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Jiangsu Konsung Bio Medical Science and Technology Co., Ltd.

Sources (1)

FDA UDI 8027cee8-7ac0-44b6-aade-463ca44714c6 35 fields · synced Jun 6, 2026