Heated CPAP Tube

GUDID 10848530090606

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

SUNSET HEALTHCARE SOLUTIONS, INC.

Heated respiratory humidifier

• Primary Device ID: 10848530090606
• NIH Device Record Key: 6f542281-2ad9-48f1-9eed-28493f455039
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heated CPAP Tube
• Version Model Number: TUB06HPR
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530090609 [Primary]
GS1	10848530090606 [Package]; Contains: 00848530090609; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201418

FDA Product Code

• BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-22
• Device Publish Date: 2021-10-14

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530089122 - Ventilator Kit: 2025-04-23 Adult Passive Heated Circuit, with Exhalation Port for Use with Philips Respironics Trilogy Comparable to OEM# 1076046, 1073227
• 00848530089375 - Suction Kit: 2025-04-23 Suction Kit This suction Kit contains: (1) RES023S, (1) RES024M, (1) RES025, and (1) TRAA001S
• 00848530096861 - Oxygen Connector: 2025-04-23 Xmas Tree Connector - Non-Swivel - 10/pack
• 00848530098728 - Mobility Support: 2025-04-23 BM001 StrongArm Comfort Cane This pack contains: (1) BM001, (1) BM001-TI, (1) BM001-BL
• 00848530104429 - Oxygen Filter: 2025-04-23 Long Life Filter for Respironics EverFlo
• 00848530104481 - CPAP Filter: 2025-04-23 Disposable Filter Comparable with LUISA Ventilator and Prisman CPAP
• 00848530104597 - CPAP Filter: 2025-04-23 3B Luna G3 Reusable Filter - 6/Pack
• 00848530104740 - CPAP Filter: 2025-04-23 Resprionics DreamStation 1 Disposable Filter - 2/Pack