Nebulizer and Compressor

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Nebulizer and Compressor FDA UDI
Generic Name: Nebulizing system delivery set, reusable FDA UDI
Device Name: Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit and Bag FDA UDI
Model / Reference: NEB100-B FDA UDI
Description: Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit and Bag FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530100377 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Nebulizing system delivery set, reusable 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Nebulizing system delivery set, reusable

Nebulizer and Compressor by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nebulizing system delivery set, reusable.

Omron Nosepiece for Nebulizer — Omron Healthcare, Inc. · Class II
Nasoneb® — MONAGHAN MEDICAL CORP. · Class I
Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
Schuco — Allied Medical LLC · Class II
Yirdoc — Qingdao Future Medical Technology Co., Ltd. · Class II
VixOne™ Reusable Nebulizer — WESTMED, INC. · Class II
Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
Portable Mesh Nebulizer — FEELLIFE HEALTH INC. · Class II

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 b28467c7-9f3a-4ac7-a824-8710a1510ac6 34 fields · synced Jun 8, 2026