Heated CPAP Tube

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Heated CPAP Tube FDA UDI
Generic Name: Heated respiratory humidifier FDA UDI
Device Name: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER) FDA UDI
Model / Reference: TUB06HPR FDA UDI
Description: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER) FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530090609 FDA UDI
510(k) Number: K201418 FDA UDI
FDA Product Code: BZE FDA UDI
GMDN Term: Heated respiratory humidifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5270 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Heated respiratory humidifier

Heated CPAP Tube by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K201418 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 6f542281-2ad9-48f1-9eed-28493f455039 35 fields · synced May 30, 2026