TRINITY

GUDID 03665134000691

KOELIS

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 03665134000691
• NIH Device Record Key: 36014d2b-6a8c-40d9-9842-e4740bc8dc59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRINITY
• Version Model Number: KURO-3000-3
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665134000684 [Primary]
GS1	03665134000691 [Package]; Contains: 03665134000684; Package: Cardboard [1 Units]; In Commercial Distribution
GS1	03665134000707 [Package]; Contains: 03665134000684; Package: Flight Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170521

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [TRINITY]

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