Vixone Reusable Nebulizer

GUDID 10709078004602

Aerosol Drug Delivery System, contains 1 reusable Vixone and 1 Nebulizer compressor

WESTMED, INC.

Nebulizing system delivery set, reusable

• Primary Device ID: 10709078004602
• NIH Device Record Key: f6ae46aa-9fc6-4cbd-8297-46f3f5de04e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vixone Reusable Nebulizer
• Version Model Number: 0398
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078004605 [Primary]
GS1	10709078004602 [Package]; Contains: 00709078004605; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800562

FDA Product Code

• BTI: Compressor, Air, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-24

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