Novasight Hybrid™ Hummingbird Console

GUDID 00628055603078

Imaging System

Conavi Medical Inc

Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system

• Primary Device ID: 00628055603078
• NIH Device Record Key: 22a01b7e-49b1-4665-9ef5-206f8d27943b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novasight Hybrid™ Hummingbird Console
• Version Model Number: TA-03-0005
• 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	00628055603078 [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

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: 2020-09-21 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: 2020-09-21Imaging System
• 00628055603078 - Novasight Hybrid™ Hummingbird Console: 2020-09-21 Imaging System