Heated CPAP Tube

GUDID 10848530090606

HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER)

SUNSET HEALTHCARE SOLUTIONS, INC.

Heated respiratory humidifier
Primary Device ID10848530090606
NIH Device Record Key6f542281-2ad9-48f1-9eed-28493f455039
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeated CPAP Tube
Version Model NumberTUB06HPR
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530090609 [Primary]
GS110848530090606 [Package]
Contains: 00848530090609
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-22
Device Publish Date2021-10-14

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530107932 - Nebulizer and Compressor2026-02-03 Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit
10848530108127 - Regulator2026-02-03 Standard CGA 870 Regulator, 1-DISS, 0-25LPM
00848530108137 - CPAP Filter2026-02-03 Filter, USA, Airsense 11, Standard, 50/Pack
10848530108158 - Regulator2026-02-03 Standard CGA 870 Regulator, 1 DISS, 0-25LPM - BULK
00848530108304 - Repair Parts2026-02-03 Attendant/Direct Supply Cabinet with Door - 2/BX
10848530108226 - REPAIR PART2026-01-27 Drive Capacitor SSP 5 Liter (OEM# 525D-616)
00848530108236 - REPAIR PARTS2026-01-27 Drive Power Cord Strap (OEM# MC29D-657) - 10/PK
10848530108240 - REPAIR PART2026-01-27 Drive Rotary Rebuilt Valve Kit
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