Beamer AVEO

Basic Information

• Brand Name: Beamer AVEO
• Primary DI: 30845854082519
• Version / Model: AVEO-CART-PKG
• Catalog Number: AVEO-CART-PKG
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-12
• Public Version: 2
• Public Version Date: 2024-02-15
• Public Version Status: Update
• Public Device Record Key: f9db265f-f97b-43ba-85d3-6b7a76d05b3f

Device Description

Beamer AVEO Cart (No Tank Holder)

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: Yes
• 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
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35124	Medical device integration rack	A device that is designed as an instrument rack (maybe cabinet-like with closed sides) and is used for mounting and organizing several medical devices that are intended to interact (integrated instrumentation). It is typically mobile (on wheels) and has built-in grounded outlets, pull-out shelves, working surfaces, and may even be equipped with a built-in transformer. This device, when supplied with the instrumentation fitted, will become a system and will require product identification of the whole as a system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	10845854082515	GS1
Primary	30845854082519	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K214058	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 60 – 106 KiloPascal