Portable Suction Machine SU100DC

GUDID 00848530088965

Portable Suction Machine

SUNSET HEALTHCARE SOLUTIONS, INC.

General-purpose suction system, line-powered

• Primary Device ID: 00848530088965
• NIH Device Record Key: f53d1c04-5f6d-4ec5-9606-2eabf068db79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable Suction Machine
• Version Model Number: SU100DC
• Catalog Number: SU100DC
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530088965 [Primary]
GS1	10848530088962 [Package]; Package: [2 Units]; 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: 2018-08-31
• Device Publish Date: 2018-07-31

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530089122 - Ventilator Kit: 2025-04-23 Adult Passive Heated Circuit, with Exhalation Port for Use with Philips Respironics Trilogy Comparable to OEM# 1076046, 1073227
• 00848530089375 - Suction Kit: 2025-04-23 Suction Kit This suction Kit contains: (1) RES023S, (1) RES024M, (1) RES025, and (1) TRAA001S
• 00848530096861 - Oxygen Connector: 2025-04-23 Xmas Tree Connector - Non-Swivel - 10/pack
• 00848530098728 - Mobility Support: 2025-04-23 BM001 StrongArm Comfort Cane This pack contains: (1) BM001, (1) BM001-TI, (1) BM001-BL
• 00848530104429 - Oxygen Filter: 2025-04-23 Long Life Filter for Respironics EverFlo
• 00848530104481 - CPAP Filter: 2025-04-23 Disposable Filter Comparable with LUISA Ventilator and Prisman CPAP
• 00848530104597 - CPAP Filter: 2025-04-23 3B Luna G3 Reusable Filter - 6/Pack
• 00848530104740 - CPAP Filter: 2025-04-23 Resprionics DreamStation 1 Disposable Filter - 2/Pack