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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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AcQMap - 00857042007265

AcQMap ECG w/Snaps Cable
ACUTUS MEDICAL, INC.
800522
Not in Commercial Distribution

  • 00857042007265 ()
800522

  • Cardiac mapping system

AcQMap - 00857042007111

AcQMap® Auxiliary Catheter Cable
ACUTUS MEDICAL, INC.
800109
Not in Commercial Distribution

  • 00857042007111 ()
800109

  • Cardiac mapping system

AcQMap - 00857042007098

AcQMap® Patient Interface Unit Cable
ACUTUS MEDICAL, INC.
800113
Not in Commercial Distribution

  • 00857042007098 ()
800113

  • Cardiac mapping system

AcQMap - 00857042007067

AcQMap® Ablation Interface Unit
ACUTUS MEDICAL, INC.
800244-001
Not in Commercial Distribution

  • 00857042007067 ()
800244-001

  • Cardiac mapping system

AcQMap - 00857042007050

AcQMap® Workstation
ACUTUS MEDICAL, INC.
800254
Not in Commercial Distribution

  • 00857042007050 ()
800254

  • Cardiac mapping system

Pure EP - 5 x 4 pin Yoked Jumper Cable Red - 00856750007178

5 cables in one bag with 4 pin yoked 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-002-016-005
In Commercial Distribution

  • 00856750007178 ()
PE-002-016-005

  • Cardiac electrophysiology analysis system

Pure EP - 5 x 4 pin Yoked Jumper Cable Yellow - 00856750007161

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

Pure EP - 5 x 10 pin Yoked Jumper Cable Green - 00856750007154

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

Pure EP - 5 x 10 pin Yoked Jumper Cable White - 00856750007130

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

Pure EP - Dual ECG Splitter Box - 00856750007123

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
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