Foresight ICE™ Catheter

GUDID 01628055603015

Imaging catheter

Conavi Medical Inc

Intracardiac ultrasound imaging catheter, steerable, single-use

• Primary Device ID: 01628055603015
• NIH Device Record Key: 10b42b18-3fd2-4f2d-8a00-265ed8b5adff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foresight ICE™ Catheter
• Version Model Number: TA-01-0001
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	00628055603016 [Primary]
GS1	01628055603015 [Package]; Contains: 00628055603016; Package: [1 Units]; In Commercial Distribution
GS1	05628055603011 [Package]; Contains: 00628055603016; Package: [5 Units]; In Commercial Distribution
GS1	10628055603013 [Package]; Contains: 00628055603016; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162789

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

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

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

Devices Manufactured by Conavi Medical Inc

• 00628055603115 - Novasight Hybrid™ Catheter: 2023-04-25 Imaging catheter consists of Novasight Hybrid Catheter, Accessory Pack and PIM Bag.
• 00628055603092 - Novasight Hybrid™ PIM: 2022-11-02 Imaging System
• 01628055603015 - Foresight ICE™ Catheter: 2020-09-21Imaging catheter
• 01628055603015 - Foresight ICE™ Catheter: 2020-09-21 Imaging catheter
• 00628055603023 - Foresight ICE™ Catheter Accessories Package: 2020-09-21 Imaging catheter accessories
• 00628055603030 - Foresight ICE™ Hummingbird Console: 2020-09-21 Imaging system
• 00628055603047 - Foresight ICE™ PIM: 2020-09-21 Imaging system
• 00628055603061 - Novasight Hybrid™ Catheter Accessories Package: 2020-09-21 Imaging catheter accessories
• 00628055603078 - Novasight Hybrid™ Hummingbird Console: 2020-09-21 Imaging System