Vyntus V-378510

GUDID 04250892904863

Vyntus APS

VYAIRE MEDICAL, INC.

Benchtop nebulizer, non-heated

• Primary Device ID: 04250892904863
• NIH Device Record Key: 9580a36a-d6f5-4674-8cfe-22cac0e19ab6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vyntus
• Version Model Number: V-378510
• Catalog Number: V-378510
• Company DUNS: 080456871
• Company Name: VYAIRE MEDICAL, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250892904863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190853

FDA Product Code

• BZC: CALCULATOR, PULMONARY FUNCTION DATA

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2021-04-09

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• 50190752200751 - LTV: 2024-08-21 Patient Circuit W/O PEEP, 22mm, SPU, Single Heated Wire, F&P