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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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5 cables in one bag with single jumper cables red to split ECG signals between two ECG devices is an accessory to the PURE EP System The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit), and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-013-005
In Commercial Distribution

  • 00856750007093 ()
PE-002-013-005

  • Cardiac electrophysiology analysis system
The ECG Cable is an accessory to the PURE EP™ System. The ECG cable Assembly (4.8m) connects to standard ECG patches on the patient’s skin. The cable connects directly to the blue plug on the amplifier (aka MSU - Main System Unit). The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit), and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-008-000
In Commercial Distribution

  • 00856750007055 ()
PE-002-008-000

  • Cardiac electrophysiology analysis system
The Catheter Input Module - IC2 J-Box Bipolar Cable Assembly (3m) is an accessory to the PURE EP™ System. The catheter input modules are used for connecting the IC catheters to the amplifier (aka MSU - Main System Unit). The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit), and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-007-000
In Commercial Distribution

  • 00856750007048 ()
PE-002-007-000

  • Cardiac electrophysiology analysis system
The Catheter Input Module - IC1 J-Box Unipolar/Bipolar Cable Assembly (3m) is an accessory to the PURE EP™ System. The catheter input modules are used for connecting the IC catheters to the amplifier (aka MSU - Main System Unit). The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit), and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-006-000
In Commercial Distribution

  • 00856750007031 ()
PE-002-006-000

  • Cardiac electrophysiology analysis system
PURE EP™ is a system consists of two main parts: the amplifier (aka MSU - Main System Unit), and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
AE-0001-412
In Commercial Distribution

  • 00856750007000 ()
PE-002-001-000

  • Cardiac electrophysiology analysis system
No Description
Vektor Medical, Inc.
VMCU2
In Commercial Distribution

  • 00860007954122 ()


  • Cardiac mapping system workstation
The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.
LUMEDX CORPORATION
1.2.5
In Commercial Distribution

  • 00857560008010 ()
113-01003

  • Cardiology information system application software
Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00300-1
In Commercial Distribution

  • 05713867000148 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
Innocor Cardio-pulmonary function test equipment
Innovision ApS
INN00100-1
In Commercial Distribution

  • 05713867000124 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
Cardio-pulmonary function test & analysis equipment
Innovision ApS
INN00100
In Commercial Distribution

  • 05713867000025 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
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