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.

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00848530096137 - Nebulizer Kit2025-05-29 Compressor Nebulizer Kit 1 kit contains T-Piece, 7ft Supply Tube, 6in Aerosol Tube, and Jet Nebulizer
00848530097363 - Limb Elbow2025-05-29 Single Limb Elbow
00848530099640 - Tracheostomy and Suction Accessory2025-05-29 Suction Canister Disposable 1200CC - 48/Case
00848530105327 - SpO2 Sensor2025-05-29 Sunset SPO2 Sensor - Neonatal/Adult (40 kg) 1.5ft cord (Similar to Masimo 2329) NON-replaceable
00848530106119 - Pediatric Cannula2025-05-29 Pediatric Soft Cannula with 7ft. Supply Tube, Universal Connector
00848530106126 - Infant Cannula2025-05-29 Infant Soft Cannula with 7ft. Supply Tube, Universal Connector
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