LumenCross Imaging Catheter

GUDID 06971141530517

Shenzhen Vivolight Medical Device & Technology Co., Ltd.

Coronary optical coherence tomography system catheter

• Primary Device ID: 06971141530517
• NIH Device Record Key: 9b83b205-daa5-40a0-85d3-4f58aedaa4cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumenCross Imaging Catheter
• Version Model Number: F2
• Company DUNS: 543028475
• Company Name: Shenzhen Vivolight Medical Device & Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971141530517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242098

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: 2025-10-06
• Device Publish Date: 2025-09-28

Devices Manufactured by Shenzhen Vivolight Medical Device & Technology Co., Ltd.

• 06971141530494 - Cornaris Intravascular Imaging System: 2025-10-06
• 06971141530500 - Cornaris Intravascular Imaging System: 2025-10-06
• 06971141530517 - LumenCross Imaging Catheter: 2025-10-06
• 06971141530517 - LumenCross Imaging Catheter: 2025-10-06
• 06971141530227 - VEINCAS: 2023-04-28