FDA.reportPublic FDA data

OptiMap™ Cable Kit - NA

Primary DI
00850064686043
Brand
OptiMap™ Cable Kit - NA
Company
Cortex, Inc.
Model
FG0011-NA
Catalog number
OPTI-CAB-NA
Device description
OptiMap Cable Kit - 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

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
00850064686043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064686043008500646860438500646860430850064686043

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable 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
00850064686111OptiMap™ ECG Cables - NAFG0012-NAOPTI-ECG-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