Avea

GUDID 10190752186248

AVEA II Ventilator - Avea Refresh

VYAIRE MEDICAL, INC.

Neonatal/adult intensive-care ventilator

• Primary Device ID: 10190752186248
• NIH Device Record Key: 37efbcda-0612-461b-8f05-e3d0fa6fd207
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avea
• Version Model 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752186248 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-28
• Device Publish Date: 2024-03-20

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• 10190752186248: AVEA II Ventilator - Avea Refresh
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