Sunset Healthcare Solutions Disposable Nebulizer Kit w/Aerosol Mask RES090

GUDID 10848530060784

Adult Nebulizer Kits - Disposable - w/ Jet Nebulizer, Aerosol Mask, 7ft O2 Tubing - 50/case

SUNSET HEALTHCARE SOLUTIONS, INC.

Aerosol face mask, rebreathing

• Primary Device ID: 10848530060784
• NIH Device Record Key: e3502f4c-979e-4752-a326-bf35d7d51e80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunset Healthcare Solutions Disposable Nebulizer Kit w/Aerosol Mask
• Version Model Number: RES090
• Catalog Number: RES090
• 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	00848530060787 [Primary]
GS1	10848530060784 [Package]; Contains: 00848530060787; 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: 3
• Public Version Date: 2018-06-19
• Device Publish Date: 2016-09-24

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