TRINITY

GUDID 03665134000547

A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart, Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.

KOELIS

General-purpose ultrasound imaging system

• Primary Device ID: 03665134000547
• NIH Device Record Key: e855f1be-b0a7-4cc9-af58-c87ffdf8d065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRINITY
• Version Model Number: KURO3000-2
• Company DUNS: 290318455
• Company Name: KOELIS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33458176810
• Email: qra@koelis.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665134000035 [Primary]
GS1	03665134000547 [Package]; Contains: 03665134000035; Package: Flight case [1 Units]; In Commercial Distribution
GS1	03665134000554 [Package]; Contains: 03665134000035; Package: cardboard [1 Units]; In Commercial Distribution

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-18
• Device Publish Date: 2019-11-08

On-Brand Devices [TRINITY]

• 03665134000547: A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen,
• 03665134000691: KURO-3000-3