DreamStation 1 Kit: 2 reusable, 6 disposable

GUDID 00848530101961

2 CF1010F DreamStation Compatible Reusable Filters 6 CF1010 DreamStation Compatible Disposable Filters

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP unit ambient air filter, single-use

• Primary Device ID: 00848530101961
• NIH Device Record Key: 7a7efce5-09e6-4c40-a128-bab3ca0da5a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamStation 1 Kit: 2 reusable, 6 disposable
• Version Model Number: AUSE001DS1S
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530101961 [Primary]

FDA Product Code

• JRL: Unit, Filter, Membrane

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: 2024-03-20
• Device Publish Date: 2024-03-12

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530108427 - Ventilator Filter: 2026-03-02 Sunset Particulate Filter for Respironics Trilogy Ventilator (OEM# 1134430) – 1/PK
• 00848530108441 - Repair Part: 2026-03-02 C1000/C1000T Primary Relief Valve, 22 PSI (OEM# B-776892-00)
• 00848530108458 - Repair Part: 2026-03-02 Companion C21/C41 Secondary Relief Valve, 30 PSI (OEM# B-775139-00)
• 00848530108465 - Bacteria Filter: 2026-03-02 Invarecare 50PSI Foam Inlet Filter - Bulk
• 00848530108434 - Oxygen Kit: 2026-02-26 Oxygen Kit (6- RES1107S, 1- RES3050G,2- RES012, 2 -RES001)
• 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)