Sunset Healthcare Solutions Disposable Nebulizer Kit w/T Mouthpiece RES091

GUDID 10848530060791

Adult Neb Kit - Disposable - w/ Jet Nebulizer, T-Piece, Mouthpiece, 6-inch Tube, 7ft O2 tube - 50/cs

SUNSET HEALTHCARE SOLUTIONS, INC.

Nebulizing system delivery set, single-use

• Primary Device ID: 10848530060791
• NIH Device Record Key: 7e31a41a-7153-4f2f-99df-3f600fe5e0e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunset Healthcare Solutions Disposable Nebulizer Kit w/T Mouthpiece
• Version Model Number: RES091
• Catalog Number: RES091
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530060794 [Primary]
GS1	10848530060791 [Package]; Contains: 00848530060794; Package: Corrugated Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091272

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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