Vena Camera Control Unit

GUDID 07540292000126

The Vena Camera Control Unit (CCU) is the compact, reusable imaging processor part of the Vena MicroAngioscope System.

Vena Medical Holdings Corp.

Flexible video angioscope

• Primary Device ID: 07540292000126
• NIH Device Record Key: 526e4209-3966-4309-bf28-1639ef09dba0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vena Camera Control Unit
• Version Model Number: GI-SYS-001
• Company DUNS: 203888110
• Company Name: Vena Medical Holdings Corp.
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540292000126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251767

FDA Product Code

• LYK: Angioscope

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: 2025-11-25
• Device Publish Date: 2025-11-17

Devices Manufactured by Vena Medical Holdings Corp.

• 07540292000126 - Vena Camera Control Unit: 2025-11-25The Vena Camera Control Unit (CCU) is the compact, reusable imaging processor part of the Vena MicroAngioscope System.
• 07540292000126 - Vena Camera Control Unit: 2025-11-25 The Vena Camera Control Unit (CCU) is the compact, reusable imaging processor part of the Vena MicroAngioscope System.
• 07540292001239 - Vena MicroAngioscope: 2025-11-25 The Vena MicroAngioscope is the sterile, single use applied part of the Vena MicroAngioscope System.