OptiMap Amplifer OPTI-AMP

GUDID 00850064686005

OptiMap Amplifier

Cortex, Inc.

Multiple physiological signal amplifier

• Primary Device ID: 00850064686005
• NIH Device Record Key: a5efd44e-6b42-4965-ad06-fbbbbad6651e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiMap Amplifer
• Version Model Number: FG0007
• Catalog Number: OPTI-AMP
• 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	00850064686005 [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: 2025-08-01OptiMap Amplifier
• 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