AVEA™

Basic Information

• Brand Name: AVEA™
• Primary DI: 10190752176836
• Version / Model: 777248
• Catalog Number: 777248
• Company Name: VYAIRE MEDICAL, INC.
• Labeler DUNS: 080456871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-09
• Public Version: 1
• Public Version Date: 2021-03-17
• Public Version Status: New
• Public Device Record Key: e9cfd3f5-c69b-4d59-b2f7-6eff0e5a11e3

Device Description

ASSY HUDSON HUMIDIFIER BRACKET

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
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43621	Desk mount	A non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190752176836	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031745	000