HELION

Primary DI
00615521031626
Brand
HELION
Company
VIDEOMED SRL
Model
116001
Catalog number
VR401111-2DT
Device description
Helion Video Integration System - Main Unit (in-room installation): - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB 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)
Published
2022-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTALight, surgical, accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615521031626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615521031626006155210316266155210316260615521031626

GMDN Terms#

Term, Definition table
TermDefinition
Operating room audiovisual data/device management systemA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
431082693
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615521031886HELION116001CM4013262022-02-11
00615521031572HELION116001VR401111-12022-02-10
00615521031589HELION116001VR4011132022-02-10
00615521031596HELION116001VR4011122022-02-10
00615521031602HELION116001VR401111-32022-02-10
00615521031619HELION116001VR401111-2T2022-02-10
00615521031633HELION116001VR401111-2D2022-02-10
00615521031640HELION116001VR401111-22022-02-10
00615521031657HELION116001VR401111-1TND2022-02-10
00615521031664HELION116001VR401111-1T2022-02-10
00615521031671HELION116001VR401111-1ND2022-02-10
00615521031688HELION116001VR401111-1DT2022-02-10
00615521031695HELION116001VR401111-1D2022-02-10

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