ImaCor Inc.

GUDID 00861589000115

Ultrasound Machine for use with ClariTEE probe

IMACOR INC

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 00861589000115
• NIH Device Record Key: 17705174-ac17-43da-afd7-9723d7a19dda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImaCor Inc.
• Version Model Number: EVO 1
• Company DUNS: 604116553
• Company Name: IMACOR INC
• 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: 6312557183
• Email: rlanzillotto@dukal.com
• Phone: 6312557183
• Email: rlanzillotto@dukal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861589000115 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-05-13
• Device Publish Date: 2017-02-10

On-Brand Devices [ImaCor Inc.]

• 00086158900201: Ultrasound Machine for use with ClariTEE probe
• 00861589000207: Ultrasound Machine for use with ClariTEE probe
• 00861589000115: Ultrasound Machine for use with ClariTEE probe