Sunset Portable Suction Machine with AC/DC Power

GUDID 10848530102576

Sunset Portable Suction Machine with AC/DC Power, 800cc Canister, Detachable Power Cord, Carry Case & Car Adapter

SUNSET HEALTHCARE SOLUTIONS, INC.

Pneumatic line tester, battery-powered

• Primary Device ID: 10848530102576
• NIH Device Record Key: 52d02887-389e-4a83-a11c-a56f0c79d691
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunset Portable Suction Machine with AC/DC Power
• Version Model Number: SU100DPA
• 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: 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
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530102579 [Primary]
GS1	10848530102576 [Package]; Contains: 00848530102579; Package: [2 Units]; Discontinued: 2024-03-05; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102626

FDA Product Code

• JCX: Apparatus, Suction, Ward Use, Portable, Ac-Powered

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