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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 4 pin yoked jumper cables yellow 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-002-015-005
In Commercial Distribution

  • 00856750007161 ()
PE-002-015-005

  • Cardiac electrophysiology analysis system
5 cables in one bag with 10 pin yoked jumper cables green 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-002-018-005
In Commercial Distribution

  • 00856750007154 ()
PE-002-018-005

  • Cardiac electrophysiology analysis system
5 cables in one bag with 10 pin yoked jumper cables blue 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-002-020-005
In Commercial Distribution

  • 00856750007147 ()
PE-002-020-005

  • Cardiac electrophysiology analysis system
5 cables in one bag with 10 pin yoked jumper cables yellow 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-002-019-005
In Commercial Distribution

  • 00856750007130 ()
PE-002-019-005

  • Cardiac electrophysiology analysis system
The Dual ECG Splitter Box is an accessory to the PURE EP™ System. It allows splitting a single array of input ECG signals into two output signals to use in conjunction with 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-002-021-000
In Commercial Distribution

  • 00856750007123 ()
PE-002-021-000

  • Cardiac electrophysiology analysis system
5 cables in one bag with single jumper cables black 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-002-017-005
In Commercial Distribution

  • 00856750007116 ()
PE-002-017-005

  • Cardiac electrophysiology analysis system
5 cables in one bag with single jumper cables black 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-002-014-005
In Commercial Distribution

  • 00856750007109 ()
PE-002-014-005

  • Cardiac electrophysiology analysis system
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
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