Heated CPAP Tube for DreamStation Series and PR System One

GUDID 00848530070670

Heated CPAP Tube for DreamStation Series and PR System One- 6ft Light Gray Smoothbore CPAP Tubing - Slim Style

SUNSET HEALTHCARE SOLUTIONS, INC.

Heated respiratory humidifier

• Primary Device ID: 00848530070670
• NIH Device Record Key: be5588c6-ab3a-4cbc-846a-8c7a2cb3817e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heated CPAP Tube for DreamStation Series and PR System One
• Version Model Number: TUB006SSRP
• 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: false
• 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
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530070670 [Primary]

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: 2024-03-13
• Device Publish Date: 2024-03-05

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530107642 - CPAP Filter: 2025-12-02 Private Labeled 3B Luna G3 and React G3X CPAP Reusable Filter - 2/Pack (pack of 20)
• 00848530107659 - Repair Part: 2025-12-02 Lip Seal for Helios - Metal
• 00848530107666 - Repair Parts: 2025-12-02 Lip Seal for Helios - Rubber
• 00848530107673 - Repair Parts: 2025-12-02 41 Contents Gauge Rebuilt
• 00848530107680 - Repair Parts: 2025-12-02 Tube Fill for C1000/C1000T
• 00848530107697 - Repair Parts: 2025-12-02 Assembly Indicator Weight for C1000/C1000T
• 00848530107703 - Repair Parts: 2025-12-02 Quick Connect Adapter for C1000/C1000T
• 00848530107710 - Repair Parts: 2025-12-02 Warming Coil for C1000