AVEA™

Basic Information

• Brand Name: AVEA™
• Primary DI: 10190752164840
• Version / Model: 10088
• Catalog Number: 10088
• Company Name: VYAIRE MEDICAL, INC.
• Labeler DUNS: 080456871
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-29
• Public Version: 3
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: e4c9d389-3372-40dd-9375-f94155b39b8b
• Distribution End Date: 2023-06-12

Device Description

Patient Circuit, Infant

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, continuous, facility use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37706	Ventilator breathing circuit, single-use	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190752164840	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]