OptiMap™ System - NA OPTI-SYS-NA

GUDID 00850064686135

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias.

Cortex, Inc.

Cardiac mapping system

• Primary Device ID: 00850064686135
• NIH Device Record Key: 0154f4d1-322d-4baa-bd24-a4f1e42413d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiMap™ System - NA
• Version Model Number: FG0001-NA
• Catalog Number: OPTI-SYS-NA
• Company DUNS: 119228234
• Company Name: Cortex, 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: false
• Lot Batch: false
• 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	00850064686135 [Primary]

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: 2025-08-01
• Device Publish Date: 2025-07-24

Devices Manufactured by Cortex, Inc.

• 00850064686005 - OptiMap Amplifer: 2025-08-01 OptiMap Amplifier
• 00850064686012 - OptiMap™ Workstation: 2025-08-01 OptiMap Workstation
• 00850064686029 - OptiMap Monitor: 2025-08-01 OptiMap Monitor
• 00850064686036 - OptiMap Cart: 2025-08-01 OptiMap Cart
• 00850064686043 - OptiMap™ Cable Kit - NA: 2025-08-01 OptiMap Cable Kit - North American
• 00850064686067 - OptiMap™ Catheter - 50mm: 2025-08-01 The OptiMap™ Catheter is a basket catheter used to detect electrical potentials from the endocardial surfaces of the heart.
• 00850064686081 - OptiMap™Catheter Extension Cable: 2025-08-01 OptiMap™ Catheter Extension Cable
• 00850064686098 - OptiMap™ System Interconnect Cable: 2025-08-01 OptiMap™ System Interconnect Cable