YUWELL Oxygen Concentrator

FDA UDI

Class II (US FDA UDI)

by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Identity

Trade Name: YUWELL Oxygen Concentrator FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: This oxygen concentrator is intended for individual use as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining. FDA UDI
Model / Reference: 8F-3A FDA UDI
Description: This oxygen concentrator is intended for individual use as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining. FDA UDI

Identifiers

Primary DI / UDI-DI: 06933257921849 FDA UDI
510(k) Number: K213825 FDA UDI
FDA Product Code: CAW FDA UDI
GMDN Term: Mobile/portable 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: Mobile/portable oxygen concentrator

YUWELL Oxygen Concentrator by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K213825 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 Yuyue Medical Equipment & Supply Co., Ltd.

Sources (1)

FDA UDI dc3fb63f-a464-4188-8137-28ae9af18d47 34 fields · synced May 30, 2026