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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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EnSite™ - 05415067049711

X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.1
In Commercial Distribution

  • 05415067049711 ()
ENSITE-TFM-3.1

  • Cardiac mapping system application software

EnSite™ - 05415067049704

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1
In Commercial Distribution

  • 05415067049704 ()
ENSITE-SW-3.1

  • Cardiac mapping system application software

ECGenius System - 05700002168535

The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
Cathvision ApS
CVT-0069 R3.0
Not in Commercial Distribution

  • 05700002168535 ()
CVT-0069 R3.0 ECGenius System

  • Cardiac electrophysiology analysis system

ECGenius System - 05700002168528

The ECGenius System is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The ECGenius System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
Cathvision ApS
CVT-0069 R2.0
Not in Commercial Distribution

  • 05700002168528 ()
CVT-0069 R2.0 ECGenius System

  • Cardiac electrophysiology analysis system

Cardio Server - 00860991000393

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
7.4.0
In Commercial Distribution

  • 00860991000393 ()


  • Cardiology information system application software

Cardio Server - 00860991000386

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
7.1
In Commercial Distribution

  • 00860991000386 ()


  • Cardiology information system application software

Cardio Server - 00860991000379

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
7.0
In Commercial Distribution

  • 00860991000379 ()


  • Cardiology information system application software

Cardio Server - 00860991000362

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
6.2
In Commercial Distribution

  • 00860991000362 ()


  • Cardiology information system application software

Cardio Server - 00860991000355

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
6.1
In Commercial Distribution

  • 00860991000355 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000348

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
6.0
In Commercial Distribution

  • 00860991000348 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000331

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.4
In Commercial Distribution

  • 00860991000331 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000324

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.3
In Commercial Distribution

  • 00860991000324 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000317

ECG Management System is a software only ECG management database that stores, displays, and prints high resolution ECG Data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.2.0
In Commercial Distribution

  • 00860991000317 ()


  • Cardiology information system application software

Epiphany Cardio Server - 00860991000300

ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
5.1.0
In Commercial Distribution

  • 00860991000300 ()


  • Cardiology information system application software

SWAN-GANZ - 00690103217704

Patient CCO cable - HemoSphere Alta advanced monitoring platform
Edwards Lifesciences LLC
HEMA70CC2
In Commercial Distribution

  • 00690103217704 ()

  • Length: 8.0000 Feet
HEMA70CC2

  • Electrical-only medical device connection cable, reusable

HEMOSPHERE - 00690103216998

Mindray OEM Pressure Smart Cable
Edwards Lifesciences LLC
PSCOEM100MR
In Commercial Distribution

  • 00690103216998 ()
PSCOEM100MR

  • General-purpose multi-parameter bedside monitor

CardioInsight™ - 00643169723689

SENSOR ARRAY VEST CITVST0004XL US
MEDTRONIC, INC.
CITVST0004XL
In Commercial Distribution

  • 00643169723689 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723672

SENSOR ARRAY VEST CITVST0003L US
MEDTRONIC, INC.
CITVST0003L
In Commercial Distribution

  • 00643169723672 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723665

SENSOR ARRAY VEST CITVST0002M US
MEDTRONIC, INC.
CITVST0002M
Not in Commercial Distribution

  • 00643169723665 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723658

SENSOR ARRAY VEST CITVST0001S US
MEDTRONIC, INC.
CITVST0001S
In Commercial Distribution

  • 00643169723658 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723603

MAPPING SYSTEM CIT200 CIT US
MEDTRONIC, INC.
CIT200
In Commercial Distribution

  • 00643169723603 ()


  • Cardiac mapping system

IOPS™ Software Application - 00843152104000

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
SW-1
In Commercial Distribution

  • 00843152104000 ()
SW-1

  • Electromagnetic surgical navigation device tracking system

IOPS® - 00843152103027

IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS). It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure.
Centerline Biomedical, Inc.
T02111
In Commercial Distribution

  • 10843152103024 ()
  • 00843152103027 ()
T02111

  • Electromagnetic surgical navigation device tracking system

IOPS™ - 00843152103003

IOPS™ Tracking Pad 1
Centerline Biomedical, Inc.
TP-1
In Commercial Distribution

  • 10843152103000 ()
  • 00843152103003 ()
TP-1

  • Electromagnetic surgical navigation device tracking system

IOPS® - 00843152102051

Guidewire Handle
Centerline Biomedical, Inc.
H01035
In Commercial Distribution

  • 10843152102058 ()
  • 00843152102051 ()
H01035

  • Electromagnetic surgical navigation device tracking system

IOPS™ - 00843152102037

Indications for Use: The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis. IOPS™ Guidewire 2 is a sensorized wire used to navigate through vasculature to facilitate placement of a catheter. The guidewire is a single-use, externally communicating device that comes into contact with circulating blood for a duration of less than or equal to 24 hours.
Centerline Biomedical, Inc.
ATW-2
In Commercial Distribution

  • 10843152102034 ()
  • 00843152102037 ()
ATW-2

  • Cardiac/peripheral vascular guidewire, single-use

IOPS™ - 00843152102013

IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system
Centerline Biomedical, Inc.
SSH-1
In Commercial Distribution

  • 10843152102010 ()
  • 00843152102013 ()
SSH-1

  • Cardiac/peripheral vascular guidewire, single-use

IOPS™ - 00843152101030

IOPS™ Catheter Reverse Curve 1
Centerline Biomedical, Inc.
RCC-1
In Commercial Distribution

  • 10843152101037 ()
  • 00843152101030 ()
RCC-1

  • Vascular guide-catheter, single-use

IOPS™ - 00843152101023

IOPS™ Catheter Simple Curve 1
Centerline Biomedical, Inc.
SCC-1
In Commercial Distribution

  • 10843152101020 ()
  • 00843152101023 ()
SCC-1

  • Vascular guide-catheter, single-use

IOPS Mobile Cart - 00843152100002

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
MC-1
In Commercial Distribution

  • 00843152100002 ()
MC-1

  • Electromagnetic surgical navigation device tracking system

EP-TRACER - 04260441452622

EP-TRACER 70 included in the cart system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
60SYS02
In Commercial Distribution

  • 04260441452622 ()


  • Cardiac electrophysiology analysis system

Aluminium carrying case - 04260441450574

No Description
CardioTek B.V.
08ACC01
In Commercial Distribution

  • 04260441450574 ()


  • Cardiac electrophysiology analysis system

Adapter cables unipolar/ bipolar (set of 10) - 04260441450482

No Description
CardioTek B.V.
03UBC02
In Commercial Distribution

  • 04260441450482 ()


  • Cardiac electrophysiology analysis system

EP-TRACER - 04260441455425

EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
40SYS02
In Commercial Distribution

  • 04260441455425 ()


  • Cardiac electrophysiology analysis system

EP-TRACER - 04260441455418

EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
40SYS01
In Commercial Distribution

  • 04260441455418 ()


  • Cardiac electrophysiology analysis system

EP-TRACER - 04260441455326

EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
32SYS02
In Commercial Distribution

  • 04260441455326 ()


  • Cardiac electrophysiology analysis system

EP-TRACER - 04260441452639

EP-TRACER 102 included in the cart system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
60SYS03
In Commercial Distribution

  • 04260441452639 ()


  • Cardiac electrophysiology analysis system

EP-TRACER - 04260441452615

EP-TRACER 38 included in the cart system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
60SYS01
In Commercial Distribution

  • 04260441452615 ()


  • Cardiac electrophysiology analysis system

Holter Prep Kit - 10812345029939

Holter prep kit with AA battery cleared with Vision 5LR recorder
MORTARA INSTRUMENT, INC.
043272
In Commercial Distribution

  • 10812345029939 ()
  • 20812345029936 ()
  • 30812345029933 ()


  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522118456

HOLTER LEADWIRES, EVO/ARIA, BROWN. 10PK
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY; ARIA
Not in Commercial Distribution

  • 10841522118456 ()
700-0369-00

  • Electrocardiographic lead set, reusable
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