AVEA

Basic Information

• Brand Name: AVEA
• Primary DI: 10846446014938
• Version / Model: 33978
• Catalog Number: 33978
• Company Name: Carefusion Corporation
• Labeler DUNS: 830432451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6e875fb5-9a7f-4e0d-af49-463786cab122

Device Description

RACK, TANK, CART ASSY, AVEA

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
41756	Gas cylinder holder	A device designed to hold and secure a single medical gas cylinder of compressed medical gas which is to be used in medical treatment/therapy. The usual gases are, [e.g., oxygen (O2), air, or nitrous oxide (N2O)]. It is used to secure the cylinder both during transport and typically whilst the gas is being used. The device is typically constructed of metal and may be mounted to a medical device service rail system, a bed under transport, or other medical devices requiring medical gas to be present. It is configured to meet the size of the cylinder, typically those of small dimensions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10846446014938	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103211	000