Infinity 3, Lite Video Router

Infinity 3, Lite Video Router
SwitchPoint Infinity, iSuite - 0678003000

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 Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OCS

Device Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Device Class: 2

Physical State: May include: ccd camera, monitor, other software or hardware associated with video equipment, and components from other regulations, such as a pump.

Definition: To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Inserted through endoscope

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various body cavities, hollow organs, and canals in GI and GU tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 07613327054255

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A