Sunset Handheld Mesh Nebulizer

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Sunset Handheld Mesh Nebulizer FDA UDI
Generic Name: Therapeutic agent nebulizer, benchtop FDA UDI
Device Name: The device is a Vibrating Mesh Nebulizer System that designed to aerosolize liquid medication for inhalation therapy by the patient. FDA UDI
Model / Reference: NEB402 FDA UDI
Description: The device is a Vibrating Mesh Nebulizer System that designed to aerosolize liquid medication for inhalation therapy by the patient. FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530098537 FDA UDI
510(k) Number: K182906 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

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Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Therapeutic agent nebulizer, benchtop

For individuals living with chronic obstructive pulmonary disease (COPD) or cystic fibrosis (CF), a portable, hand-held mesh nebulizer is essential for effective inhalation therapy. The Sunset Handheld Mesh Nebulizer is designed to provide high-quality aerosolization of medication/fluids using an electrically-powered generator and a nebulizing chamber. Its features include a compact design, easy-to-use interface, and disposable attachments for comfortable inhalation.

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Cleared under the same submission

K182906 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: SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

FDA UDI 0ff900f7-bc06-483f-88ec-23f840bf8078 35 fields · synced Jul 15, 2026