Handheld Compressor Nebulizer

GUDID 00848530099497

Handheld Compressor Nebulizer - Compressor Unit Only

SUNSET HEALTHCARE SOLUTIONS, INC.

Benchtop nebulizer, non-heated

• Primary Device ID: 00848530099497
• NIH Device Record Key: 46127bd6-2afb-4180-b273-5c2629e84bf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handheld Compressor Nebulizer
• Version Model Number: NEB200A
• 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: false
• 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	00848530099497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182906

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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

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• 00848530105334 - SPO2 Sensor: 2025-06-11 Sunset SPO2 Sensor - Neonatal/Adult 3ft cord- NON-replaceable
• 10848530105348 - SpO2 Sensor: 2025-06-11 Sunset SPO2 Sensor - Infant (3-20kg) - 1.5ft cord
• 00848530105358 - SpO2 Sensor: 2025-06-11 Sunset SPO2 Sensor - Pediatric (10-50kg) - 1.5ft cord