Nebulizer(direct patient interface)

FDA UDI

Class II (US FDA UDI)

by Chen Qian Electronic Commerce (Hangzhou) Co., Ltd.

Identity

Trade Name: Nebulizer(direct patient interface) FDA UDI
Generic Name: Therapeutic agent nebulizer, benchtop FDA UDI
Device Name: This unit operates on standard AC power. Treatments are delivered quickly, safely, and conveniently, making this unit ideal for all ages.This nebulizer should be used under the supervision of a licensed physician and/or a respiratory therapist. With you physician and/or respiratory therapist, you will feel comfortable and confident knowing that you are obtaining the most effective inhalation treatments for your respiratory condition. FDA UDI
Model / Reference: WHQ-1902WH(408D) FDA UDI
Description: This unit operates on standard AC power. Treatments are delivered quickly, safely, and conveniently, making this unit ideal for all ages.This nebulizer should be used under the supervision of a licensed physician and/or a respiratory therapist. With you physician and/or respiratory therapist, you will feel comfortable and confident knowing that you are obtaining the most effective inhalation treatments for your respiratory condition. FDA UDI

Identifiers

Primary DI / UDI-DI: 06973401840015 FDA UDI
510(k) Number: K003344 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Therapeutic agent nebulizer, benchtop FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Therapeutic agent nebulizer, benchtop

Nebulizer(direct patient interface) by Chen Qian Electronic Commerce (Hangzhou) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K003344 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: Chen Qian Electronic Commerce (Hangzhou) Co., Ltd.

Sources (1)

FDA UDI 738b49ab-68c3-4f51-92b2-81748cfd439d 34 fields · synced May 31, 2026