VixOne Nebulizer

GUDID 10709078004954

VixOne Nebulizer w/ Adult Elongated Mask

WESTMED, INC.

Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable

• Primary Device ID: 10709078004954
• NIH Device Record Key: e1a88443-c5a4-49e5-9a0e-4055a577a60c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VixOne Nebulizer
• Version Model Number: 0327
• 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	00709078004957 [Primary]
GS1	10709078004954 [Package]; Contains: 00709078004957; 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: 2017-10-20

On-Brand Devices [VixOne Nebulizer]

• 10709078006194: VixOne Nebulizer 7' Tubing
• 10709078004961: VixOne Nebulizer w/ Pediatric Elongated Mask
• 10709078004954: VixOne Nebulizer w/ Adult Elongated Mask
• 00709078001574: Bulk packaged
• 00709078000676: Bulk Packaged