SEARCH RESULTS FOR: ("NWSE MAPS")(205 results)

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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 Class Implantable

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Ablamap® System - 00860457001568

The Ablamap® System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and workstation that contains proprietary mapping software. Signals are transmitted from a 64-electrode mapping “basket” catheter, through the amplifier, to the workstation, processed by the mapping software, and the results are displayed on the monitor.
Ablacon Inc.
AB-0007
In Commercial Distribution

  • 00860457001568 ()


  • Cardiac mapping system computer

Navik 3D - 00869781000308

Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed. Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care.
APN HEALTH
Navik 3D v2.0
In Commercial Distribution

  • 00869781000308 ()
200-00668

  • Cardiac mapping system computer

vMap Control Unit - 00860007954177

No Description
Vektor Medical, Inc.
VMCU1
In Commercial Distribution

  • 00860007954177 ()


  • Cardiac mapping system computer

vMap Disposables - 00860007954108

No Description
Vektor Medical, Inc.
VMDISP1
In Commercial Distribution

  • 00860007954108 ()


  • Cardiac mapping system computer

GEMS Win HL7 - 00812324000266

HL7 plug-in module for GEMS Win
CardioComm Solutions, Inc
GW-HL7
In Commercial Distribution

  • 00812324000266 ()
GW-HL7

  • Cardiac mapping system computer

GEMS Win Air - 00812324000259

GEMS Win Air
CardioComm Solutions, Inc
GW-AIR
In Commercial Distribution

  • 00812324000259 ()
GW-AIR

  • Cardiac mapping system computer

GEMS Win AutoAttendant - 00812324000242

GEMS Win AutoAttendant
CardioComm Solutions, Inc
GW-AA
In Commercial Distribution

  • 00812324000242 ()
GW-AA

  • Cardiac mapping system computer

GEMS Win TTM & ICD - 00812324000228

GEMS Win ARR TTM & Full Pacing
CardioComm Solutions, Inc
GW-TTMICD
In Commercial Distribution

  • 00812324000228 ()
GW-TTMICD

  • Cardiac mapping system computer

GEMS Win TTM - 00812324000211

Global ECG Management System for Windows with Arrhythmia and TTM
CardioComm Solutions, Inc
GW-TTM
In Commercial Distribution

  • 00812324000211 ()
GW-TTM

  • Cardiac mapping system computer

GEMS Win Arrhythmia - 00812324000204

Global ECG Management System (GEMS) for Windows Arrhythmia
CardioComm Solutions, Inc
GW-ARR
In Commercial Distribution

  • 00812324000204 ()
GW-ARR

  • Cardiac mapping system computer

TactiSys™ - 07640157990316

Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer

TactiSys™ - 07640157990194

Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer

Gyrus ACMI - 00821925018075

COTTLE SKIN HOOK LONG EBONY FINISH
Gyrus ACMI, LLC
270210
Not in Commercial Distribution

  • 00821925018075 ()


  • Cardiac mapping system computer

VISITAG EXT PROCESSING UNIT ACCESS - 10846835018585

DOCK, VISITAG SURPOINT EPU SP
Biosense Webster Inc
M665701SP
In Commercial Distribution

  • 10846835018585 ()
M665701SP

  • Cardiac mapping system computer

VISITAG SURPOINT EPU SPARE - 10846835018578

EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660201SP
In Commercial Distribution

  • 10846835018578 ()
M660201SP

  • Cardiac mapping system computer

VISITAG SURPOINT EPU - 10846835018554

EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660202SP
In Commercial Distribution

  • 10846835018554 ()
M660202SP

  • Cardiac mapping system computer

VISITAG SURPOINT External Processing Unit - 10846835017885

External Processing Unit
Biosense Webster Inc
D160801
In Commercial Distribution

  • 10846835017885 ()
D160801

  • Cardiac mapping system computer

Volta AF-Xplorer - 03770019196038

Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A002
In Commercial Distribution

  • 03770019196038 ()
A002

  • Cardiac mapping system computer

VX1 - 03770019196007

Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A001
In Commercial Distribution

  • 03770019196007 ()
A001

  • Cardiac mapping system computer

McKesson Cardiology ECG Management - 80010939040028

No Description
Change Healthcare Canada Company
14.0
In Commercial Distribution

  • 80010939040028 ()


  • Cardiac mapping system computer

McKesson Cardiology ECG Management - 80010939040011

No Description
Change Healthcare Canada Company
13.2.1
In Commercial Distribution

  • 80010939040011 ()


  • Cardiac mapping system computer

Change Healthcare Cardiology ECG Mobile - 17540262120028

No Description
CHANGE HEALTHCARE ISRAEL LTD
1.3
Not in Commercial Distribution

  • 17540262120028 ()


  • Cardiac mapping system computer

Change Healthcare Cardiology ECG Mobile - 17540262120011

No Description
CHANGE HEALTHCARE ISRAEL LTD
1.2.4
Not in Commercial Distribution

  • 17540262120011 ()


  • Cardiac mapping system computer

Change Healthcare Cardiology ECG Management - 17540262110135

No Description
Change Healthcare Canada Company
15.1.1
In Commercial Distribution

  • 17540262110135 ()


  • Cardiac mapping system computer

Change Healthcare Cardiology ECG Management - 17540262110128

No Description
Change Healthcare Canada Company
15.1
In Commercial Distribution

  • 17540262110128 ()


  • Cardiac mapping system computer

Change Healthcare Cardiology ECG Management - 17540262110104

No Description
Change Healthcare Canada Company
15.0.1
In Commercial Distribution

  • 17540262110104 ()


  • Cardiac mapping system computer

Change Healthcare Cardiology ECG Management - 17540262110098

No Description
Change Healthcare Canada Company
15.0
In Commercial Distribution

  • 17540262110098 ()


  • Cardiac mapping system computer

Change Healthcare Cardiology ECG Management - 17540262110050

No Description
Change Healthcare Canada Company
14.3.2
In Commercial Distribution

  • 17540262110050 ()


  • Cardiac mapping system computer

Change Healthcare Cardiology ECG Management - 17540262110043

No Description
Change Healthcare Canada Company
14.3
In Commercial Distribution

  • 17540262110043 ()


  • Cardiac mapping system computer

Change Healthcare Cardiology ECG Management - 17540262110036

No Description
Change Healthcare Canada Company
14.2
In Commercial Distribution

  • 17540262110036 ()


  • Cardiac mapping system computer
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