FDA.reportPublic FDA data

OptiMap Cart

Primary DI
00850064686036
Brand
OptiMap Cart
Company
Cortex, Inc.
Model
FG0010
Catalog number
OPTI-CART
Device description
OptiMap Cart
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064686036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064686036008500646860368500646860360850064686036

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

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

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
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
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
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
17540279200027CardioSTATIcentia Inc.DQK2025-12-08
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
B353UA2251DA1UbiqVueLifesignals, Inc.DQK2025-04-22
B353UA2251SA1UbiqVueLifesignals, Inc.DQK2025-04-22
27540279250029CardioSTATIcentia Inc.DQK2024-12-18
27540279250074CardioSTATIcentia Inc.DQK2024-12-18
27540279250142CardioSTATIcentia Inc.DQK2024-12-18
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
17540279200140CardioSTATIcentia Inc.DQK2024-03-26
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
08800069700178AT-PatchATsens Co., Ltd.DQK2022-12-23
B273CEA0Cardiologs PlatformCARDIOLOGS TECHNOLOGIESDQK2021-12-08
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982876MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
00191506015084AVVIGO™ Guidance System IIBOSTON SCIENTIFIC CORPORATIONDQK2021-11-17
00191506015169AVVIGO™ Guidance System IIBOSTON SCIENTIFIC CORPORATIONDQK2021-11-17
00191506015176AVVIGO™ Guidance System IIBOSTON SCIENTIFIC CORPORATIONDQK2021-11-17