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.

• 00848530040291 - Oxygen Masks: 2024-08-23 Sunset Breathing Mask, No Hook s - Adult Small
• 00848530040307 - Oxygen Masks: 2024-08-23 Sunset Breathing Mask, No Hooks - Adult Medium
• 00848530040314 - Oxygen Masks: 2024-08-23 Sunset Breathing Mask, No Hooks - Adult Large
• 00848530104214 - Oxygen Masks: 2024-08-23 Sunset Breathing Mask, No Hooks - Infant
• 00848530104221 - Oxygen Masks: 2024-08-23 Sunset Breathing Mask, No Hooks - Toddler
• 10848530091290 - Power and Accessories: 2024-08-16 Portable Suction Machine DC Mobile Power Adapter
• 00848530091378 - Portable Suction: 2024-08-16 Portable Suction Machine AC
• 10848530091870 - Power and Accessories: 2024-08-16 Replacement Battery for SU100DC Portable Suction Machine