FDA.reportPublic FDA data

OptiMap™ ECG Cables - NA

Primary DI
00850064686111
Brand
OptiMap™ ECG Cables - NA
Company
Cortex, Inc.
Model
FG0012-NA
Catalog number
OPTI-ECG-NA
Device description
OptiMap ECG Cables - North American
Published
2025-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064686111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064686111008500646861118500646861110850064686111

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system reference patchA component of a cardiac mapping system that is an adhesive device placed on the surface of a patient's body, typically the chest and/or back, to provide a fixed reference point for the tip of an internal, non-fluoroscopic catheter during an electrophysiological and electromechanical real-time mapping of the heart. It may be sensor-containing or have a sensor attached to it, and is used to compensate for patient movement during the procedure. It is typically used with a cardiac mapping system computer to assist in the location and navigation of the catheter tip, and to provide electrocardiogram information. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119228234
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850064686166OptiMap Catheter - 60mmOPTI-CATH2-602026-05-15
00850064686159OptiMap Catheter - 50mmOPTI-CATH2-502026-04-02
00850064686043OptiMap™ Cable Kit - NAFG0011-NAOPTI-CAB-NA2025-07-24
00850064686067OptiMap™ Catheter - 50mmFG0003-50OPTI-CATH-502025-07-24
00850064686104OptiMap™ Fiber Optic CableOPTI-FOCFG00062025-07-24
00850064686135OptiMap™ System - NAFG0001-NAOPTI-SYS-NA2025-07-24
00850064686074OptiMap™ Catheter - 60mmFG0003-60OPTI-CATH-602025-07-10
00850064686005OptiMap AmpliferFG0007OPTI-AMP2025-07-24
00850064686012OptiMap™ WorkstationFG0008OPTI-WS2025-07-24
00850064686029OptiMap MonitorFG0009OPTI-MON2025-07-24
00850064686036OptiMap CartFG0010OPTI-CART2025-07-24
00850064686098OptiMap™ System Interconnect CableFG0005OPTI-SIC2025-07-24
00850064686081OptiMap™Catheter Extension CableFG0004OPTI-CEC2025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416606898FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606904FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606911FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606928FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606935FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606942FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606959FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
07613327666809N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.DSA2025-02-24
G096DR5PS05009LineRising Eagle Medical LLCDSA2024-09-17
G096GE5PS05009LineRising Eagle Medical LLCDSA2024-09-17
G096GE5VPS05009LineRising Eagle Medical LLCDSA2024-09-17
G096PS3SS05009LineRising Eagle Medical LLCDSA2024-09-17
G096PS5PS05009LineRising Eagle Medical LLCDSA2024-09-17
G096PS5SS05009LineRising Eagle Medical LLCDSA2024-09-17
G096PS5VPS05009LineRising Eagle Medical LLCDSA2024-09-17
G096PS5VSS05009LineRising Eagle Medical LLCDSA2024-09-17
G096MPS5PSC0500MEDALinkRising Eagle Medical LLCDSA2024-04-09
G096MGE3PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MGE5PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MGE5VPS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MNK3PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MNK6PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MPS3PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MPS5PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MPS5VPS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MA0001D030MEDALinkRising Eagle Medical LLCDSA2023-04-28
G096MA0001D060MEDALinkRising Eagle Medical LLCDSA2023-04-28
G096MA0002D050MEDALinkRising Eagle Medical LLCDSA2023-03-22
G096MA0002D050020MEDALinkRising Eagle Medical LLCDSA2023-03-22