OptiMap Monitor OPTI-MON

GUDID 00850064686029

OptiMap Monitor

Cortex, Inc.

Cardiac mapping system
Primary Device ID00850064686029
NIH Device Record Key7df20280-a357-4fb8-855f-494dd6878f84
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiMap Monitor
Version Model NumberFG0009
Catalog NumberOPTI-MON
Company DUNS119228234
Company NameCortex, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850064686029 [Primary]

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-01
Device Publish Date2025-07-24

Devices Manufactured by Cortex, Inc.

00850064686005 - OptiMap Amplifer2025-08-01 OptiMap Amplifier
00850064686012 - OptiMap™ Workstation2025-08-01 OptiMap Workstation
00850064686029 - OptiMap Monitor2025-08-01OptiMap Monitor
00850064686029 - OptiMap Monitor2025-08-01 OptiMap Monitor
00850064686036 - OptiMap Cart2025-08-01 OptiMap Cart
00850064686043 - OptiMap™ Cable Kit - NA2025-08-01 OptiMap Cable Kit - North American
00850064686067 - OptiMap™ Catheter - 50mm2025-08-01 The OptiMap™ Catheter is a basket catheter used to detect electrical potentials from the endocardial surfaces of the heart.
00850064686081 - OptiMap™Catheter Extension Cable2025-08-01 OptiMap™ Catheter Extension Cable
00850064686098 - OptiMap™ System Interconnect Cable2025-08-01 OptiMap™ System Interconnect Cable
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