AVEA II 32029-001

GUDID 10846446066074

AVEA VENTILATOR

VYAIRE MEDICAL, INC.

Neonatal/adult intensive-care ventilator

• Primary Device ID: 10846446066074
• NIH Device Record Key: bbbb91d7-c42e-4028-8290-29cb32779315
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVEA II
• Version Model Number: 32029-001
• Catalog Number: 32029-001
• 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: false
• 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: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM
• Phone: 833-327-3284
• Email: CUSTOMERSUPPORT@VYAIRE.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846446066074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103211

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 2024-06-18
• Device Publish Date: 2018-04-05

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• 50190752200829 - LTV: 2024-11-13 Patient Circuit W/O PEEP, 22mm, SPU, Dual Heated Wire, F&P
• 10190752201019 - 3100 HFOV: 2024-11-13 Tube Set, Filtered Patient Circuit
• 10190752201118 - LTV: 2024-11-13 Patient Circuit Ventilator Adapter
• 50190752201536 - LTV: 2024-11-13 Patient Circuit, W/ PEEP, 15mm, SPU
• 50190752200751 - LTV: 2024-08-21 Patient Circuit W/O PEEP, 22mm, SPU, Single Heated Wire, F&P