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

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• 00848530108137 - CPAP Filter: 2026-02-03 Filter, USA, Airsense 11, Standard, 50/Pack
• 10848530108158 - Regulator: 2026-02-03 Standard CGA 870 Regulator, 1 DISS, 0-25LPM - BULK
• 00848530108304 - Repair Parts: 2026-02-03 Attendant/Direct Supply Cabinet with Door - 2/BX
• 10848530108226 - REPAIR PART: 2026-01-27 Drive Capacitor SSP 5 Liter (OEM# 525D-616)
• 00848530108236 - REPAIR PARTS: 2026-01-27 Drive Power Cord Strap (OEM# MC29D-657) - 10/PK
• 10848530108240 - REPAIR PART: 2026-01-27 Drive Rotary Rebuilt Valve Kit