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.

• 00848530108311 - Oxygen Kit: 2026-02-19 10L Oxygen Supply Kit 4 RES1107SHF High Flow Soft Cannula with 7ft Supply Tube 2 RES003 No Smoking Sign 2 RES3025G Oxygen Suppl
• 00848530108335 - Repair Parts: 2026-02-19 CAIRE Contents Gauge Tubing (OEM# B-775856-SV) - 2/PK
• 00848530108342 - Repair Parts: 2026-02-19 C1000/C1000T Portable Rubber Foot - 56/Sheet - 10 Sheet/Case - (OEM# B-775010-00)
• 00848530108168 - Regulators: 2026-02-10 Private Labeled - Standard CGA 870 Regulator, 1-DISS, 0-25LPM
• 10848530108172 - CPAP Accessory: 2026-02-10 Sunset Nasal Gel Pad - 5/PK
• 00848530108267 - Filter - Vent: 2026-02-10 Luisa Gross Particle Internal Filter - 1/PK
• 10848530108271 - CPAP Tubing: 2026-02-10 Adapter for Resmed S10 Heated CPAP Tube System
• 00848530108298 - CPAP Filter: 2026-02-04 Filter, USA, Standard S9, AirSense 10, AirCurve, 2/pack