VIVO Positioning Patches 9208

GUDID 00085142400710

Patches are placed on the shoulder and sternum of the patient to acquire an image for VIVO analysis.

Catheter Precision, Inc.

Cardiac mapping system application software

• Primary Device ID: 00085142400710
• NIH Device Record Key: 92581835-2d3a-4167-9bc5-0798cf48e5ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVO Positioning Patches
• Version Model Number: 9208
• Catalog Number: 9208
• Company DUNS: 131845013
• Company Name: Catheter Precision, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00085142400710 [Package]; Contains: 00851424007102; Package: Case [5 Units]; In Commercial Distribution
GS1	00851424007102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200313

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2026-02-11
• Device Publish Date: 2026-02-03

Devices Manufactured by Catheter Precision, Inc.

• 00851424007089 - VIVO: 2026-02-11 VIVO™ uses standard clinical inputs and proprietary algorithms to create patient-specific anatomy, provide a 3D image of the h
• 00085142400710 - VIVO Positioning Patches: 2026-02-11Patches are placed on the shoulder and sternum of the patient to acquire an image for VIVO analysis.
• 00085142400710 - VIVO Positioning Patches: 2026-02-11 Patches are placed on the shoulder and sternum of the patient to acquire an image for VIVO analysis.
• 00851424007119 - VIVO System: 2026-02-11 VIVO™ uses standard clinical inputs and proprietary algorithms to create patient-specific anatomy, provide a 3D image of the h
• 00851424007157 - LockeT Suture Retention Device: 2026-01-21 LockeT is a safe and effective suture retention device that is used in conjunction with a figure-of-eight suture to achieve hemo