Sunset Healthcare Solutions Reusable Nebulizer Kit

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Sunset Healthcare Solutions Reusable Nebulizer Kit FDA UDI
Generic Name: Nebulizing system delivery set, single-use FDA UDI
Device Name: Reusable Nebulizer Kit, includes: T-Piece, Mouthpiece, 7ft Supply Tube, Corrugated Reservoir Tube and Nebulizer Bottle. FDA UDI
Model / Reference: RES093 FDA UDI
Description: Reusable Nebulizer Kit, includes: T-Piece, Mouthpiece, 7ft Supply Tube, Corrugated Reservoir Tube and Nebulizer Bottle. FDA UDI

Identifiers

Catalog Number: RES093 FDA UDI
Primary DI / UDI-DI: 00848530062330 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Nebulizing system delivery set, single-use 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

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nebulizing system delivery set, single-use

Sunset Healthcare Solutions Reusable Nebulizer Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID

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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 4e94e90e-4f08-46df-ab9f-93faf4627921 35 fields · synced May 30, 2026