Nebulizer Mask

GUDID 00848530090401

Adult Mask for use with NEB400 Mini Mesh Nebulizer

SUNSET HEALTHCARE SOLUTIONS, INC.

Ambulatory nebulizer, non-heated

• Primary Device ID: 00848530090401
• NIH Device Record Key: ea0117dd-958f-4720-b900-52f7c71a27f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nebulizer Mask
• Version Model Number: NEB400-MASKA
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530090401 [Primary]

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: 2024-06-17
• Device Publish Date: 2024-06-07

On-Brand Devices [Nebulizer Mask]

• 00848530092566: Adult Mask for use with NEB401 Mesh Nebulizer
• 00848530090401: Adult Mask for use with NEB400 Mini Mesh Nebulizer
• 00848530092573: Pediatric Mask for use with NEB401 Mesh Nebulizer
• 00848530090395: Pediatric Mask for use with NEB400 Mini Mesh Nebulizer
• 00848530099916: Replacement Pediatric Mask for NEB402
• 00848530099909: Replacement Adult Mask for NEB402