Disposable Intracardiac Echocardiography Catheter

GUDID 16975345061102

Jiangsu Tingsn Technology Co., Ltd.

Intracardiac ultrasound imaging catheter, steerable, single-use

• Primary Device ID: 16975345061102
• NIH Device Record Key: 95b6256c-07e8-42b8-9462-0d724115cda0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Intracardiac Echocardiography Catheter
• Version Model Number: TINGSN Sonic Eyes 10 Eco
• Company DUNS: 603360725
• Company Name: Jiangsu Tingsn Technology Co., Ltd.
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	16975345061102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250913

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

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: 2026-02-09
• Device Publish Date: 2026-01-31

Devices Manufactured by Jiangsu Tingsn Technology Co., Ltd.

• 06975345060108 - Color Doppler Diagnostic Ultrasound System: 2026-02-09
• 16975345061102 - Disposable Intracardiac Echocardiography Catheter: 2026-02-09
• 16975345061102 - Disposable Intracardiac Echocardiography Catheter: 2026-02-09