Sunset Heated CPAP Tube TUB06HPR-E

GUDID 00848530102753

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

SUNSET HEALTHCARE SOLUTIONS, INC.

Heated respiratory humidifier
Primary Device ID00848530102753
NIH Device Record Key74240e3f-9212-42cb-9ccf-596e7c80dd28
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunset Heated CPAP Tube
Version Model NumberTUB06HPR-E
Catalog NumberTUB06HPR-E
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
GS100848530102753 [Primary]

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 Date2024-02-28
Device Publish Date2024-02-20

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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