Novasight Hybrid™ PIM

GUDID 00628055603085

Imaging System

Conavi Medical Inc

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: 00628055603085
• NIH Device Record Key: ed676b1c-8d66-4780-af38-86fd7baac77a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novasight Hybrid™ PIM
• Version Model Number: TA-07-0001
• Company DUNS: 200125243
• Company Name: Conavi Medical 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: false
• 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: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055603085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172258

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

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: 2020-09-21
• Device Publish Date: 2020-09-11

On-Brand Devices [Novasight Hybrid™ PIM]

• 00628055603085: Imaging System
• 00628055603092: Imaging System