HELION

Basic Information

• Brand Name: HELION
• Primary DI: 00615521031664
• Version / Model: 116001
• Catalog Number: VR401111-1T
• Company Name: VIDEOMED SRL
• Labeler DUNS: 431082693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-10
• Public Version: 3
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: 7d547570-8da9-48d1-a95e-b5464fbb3875

Device Description

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high- profile compression)

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: Yes
• 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
FTA	Light, surgical, accessories	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58117	Operating room audiovisual data/device management system	A mains electricity (AC-powered) device assembly designed to provide operating room (OR) staff with a single point of management to operate electromechanical/electronic medical devices of different makes during surgery. It is a computer-based integrated hardware/software application that typically consists of a base unit (outside the sterile field or the OR) to which all device cabling is connected, and software that runs on an off-the-shelf computer with a touchscreen (in the OR). The system is intended to manipulate devices such as OR lights, OR tables, cameras, video endoscope images, and monitors; it may also be used to manage patient data from these devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615521031664	GS1

Customer Contacts

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