AVEA

Basic Information

• Brand Name: AVEA
• Primary DI: 10190752174801
• Version / Model: 68339K
• Catalog Number: 68339K
• Company Name: VYAIRE MEDICAL, INC.
• Labeler DUNS: 080456871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-07
• Public Version: 1
• Public Version Date: 2021-05-17
• Public Version Status: New
• Public Device Record Key: f5ebb250-0222-4d17-8fef-66d4416b7d06

Device Description

BATTERY ASSEMBLY, 24V, 4.5AH, NIMH, AVEA

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
38489	Uninterruptible power supply	A portable device, commonly known as an uninterruptible power supply (UPS), designed to provide a continuous supply of electrical power for a limited period of time to a connected device or devices during the failure of the mains electricity (AC-power) supply due to an emergency situation, e.g., a blackout, or maintenance/testing. It will contain its own set of batteries that normally maintain their charge from the mains power supply and it is these that provide the power when a failure in the line-power occurs. This device is used locally (at the point of use) and is often reserved to supply vital devices, e.g., ventilators, patient monitoring devices and computer dependent devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190752174801	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103211	000