MADA Aerosol Mask Kits

GUDID 00709078001963

VixOne Nebulizer with Adult Aerosol Mask (With Single Vents)

WESTMED, INC.

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• Primary Device ID: 00709078001963
• NIH Device Record Key: e1bdb1b6-6464-4ac1-a233-2abb84af92ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MADA Aerosol Mask Kits
• Version Model Number: 50310
• Company DUNS: 092673953
• Company Name: WESTMED, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078001963 [Primary]
GS1	10709078001960 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800562

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: 2018-07-06
• Device Publish Date: 2016-12-16

On-Brand Devices [MADA Aerosol Mask Kits]

• 10709078001977: VixOne Nebulizer with Pediatric Aerosol Mask (With Single Vents)
• 00709078001963: VixOne Nebulizer with Adult Aerosol Mask (With Single Vents)