Vena MicroAngioscope

GUDID 07540292001239

The Vena MicroAngioscope is the sterile, single use applied part of the Vena MicroAngioscope System.

Vena Medical Holdings Corp.

Flexible video angioscope

• Primary Device ID: 07540292001239
• NIH Device Record Key: 2c870be7-185a-4f3b-8ef3-e623a0f42074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vena MicroAngioscope
• Version Model Number: GI-DSP-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: 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	07540292001239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251767

FDA Product Code

• LYK: Angioscope

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

Devices Manufactured by Vena Medical Holdings Corp.

• 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: 2025-11-25The Vena MicroAngioscope is the sterile, single use applied 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.