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Ampere® Adapter Cable
AcQMap® Ampere
ACUTUS MEDICAL, INC.
800431
Not in Commercial Distribution
- 00857042007135 ()
800431
- Cardiac mapping system
AcQMap® Surface ECG Cable
ACUTUS MEDICAL, INC.
800407
Not in Commercial Distribution
- 00857042007128 ()
800407
- Cardiac mapping system
AcQMap® Auxiliary Catheter Cable
ACUTUS MEDICAL, INC.
800109
Not in Commercial Distribution
- 00857042007111 ()
800109
- Cardiac mapping system
AcQMap® Ablation Interface Unit Cable
ACUTUS MEDICAL, INC.
800112
Not in Commercial Distribution
- 00857042007104 ()
800112
- Cardiac mapping system
AcQMap® Patient Interface Unit Cable
ACUTUS MEDICAL, INC.
800113
Not in Commercial Distribution
- 00857042007098 ()
800113
- Cardiac mapping system
AcQMap® Patient Interface Unit
ACUTUS MEDICAL, INC.
800229
Not in Commercial Distribution
- 00857042007081 ()
800229
- Cardiac mapping system
Ampere® Adapter Cable
AcQMap® Ablation Catheter
ACUTUS MEDICAL, INC.
800430
Not in Commercial Distribution
- 00857042007074 ()
800430
- Cardiac mapping system
AcQMap® Ablation Interface Unit
ACUTUS MEDICAL, INC.
800244-001
Not in Commercial Distribution
- 00857042007067 ()
800244-001
- Cardiac mapping system
AcQMap® Workstation
ACUTUS MEDICAL, INC.
800254
Not in Commercial Distribution
- 00857042007050 ()
800254
- Cardiac mapping system
AcQMap® Console
ACUTUS MEDICAL, INC.
800258
Not in Commercial Distribution
- 00857042007043 ()
800258
- Cardiac mapping system
North America Power Cord
ACUTUS MEDICAL, INC.
800426
Not in Commercial Distribution
- 00857042007005 ()
800426
- Cardiac mapping system
License dongle for second workstation using the HolterCare software.
SCOTTCARE CORPORATION, THE
HolterCare Editing Kit
In Commercial Distribution
- 00856298006268 ()
100080
- Electrocardiographic long-term ambulatory recording analyser application software
The ScottCare HolterCare Analysis System is intended for general hospital or clinical use by
medical professionals whenever it is required to assess a patient’s long-term, continuous,
ambulatory electrocardiogram (ECG). The long-term ECG is recorded on a digital flash memory
Holter recorder. This product allows a trained physician, or other health care professional, to
download and analyze the data from the recorder, review it, and produce printed reports. This will
enable:
The evaluation of arrhythmias and ischemic attacks.
The reporting of PQRST intervals.
Clinical and epidemiological research studies.
The evaluation of a patient’s response after resuming occupational or recreational activities (e.g.,
after M.I. or cardiac surgery).
The evaluation of patients with Pacemakers.
The need to record, review, edit, and archive the ambulatory ECG is most commonly encountered in
the Cardiology areas of the hospital, or physician’s office, during cardiac assessment of a patient.
This device is available for sale to, or on the order of, a licensed physician only and is not intended
for any home-use applications.
SCOTTCARE CORPORATION, THE
HolterCare
In Commercial Distribution
- 00856298006169 ()
100087
- Electrocardiographic long-term ambulatory recording analyser application software
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
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
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
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
No Description
Vektor Medical, Inc.
VMDISP2
In Commercial Distribution
- 00860007954115 ()
- Cardiac mapping system workstation
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
STAR Apollo Mapping System
- Cardiac mapping system application software
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
Not in Commercial Distribution
- 00860009793507 ()
STAR Apollo Mapping System
- Cardiac mapping system application software
No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE V2
In Commercial Distribution
- 00840682109772 ()
- Cardiac stress exercise monitoring system
No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE A/T V2
In Commercial Distribution
- 00840682109611 ()
- Cardiac stress exercise monitoring system
CARDIOSOFT V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
In Commercial Distribution
- 00840682105170 ()
- Electrocardiograph, professional, multichannel
CS V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
Not in Commercial Distribution
- 00840682105156 ()
- Electrocardiograph, professional, multichannel
CASE V6.7
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.7
In Commercial Distribution
- 00840682105088 ()
- Electrocardiograph, professional, multichannel
No Description
GE Healthcare Finland Oy
E-COP-01
In Commercial Distribution
- 00840682104104 ()
- Patient monitoring system module, multifunction
No Description
GE Healthcare Finland Oy
E-COPSv-01
In Commercial Distribution
- 00840682104098 ()
- Patient monitoring system module, multifunction
No Description
Biosense Webster Inc
D128624
In Commercial Distribution
- 10846835012576 ()
D128624
- Electrical-only medical device connection cable, reusable
NOGA XP-Cardiac Mapping System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG170000
Not in Commercial Distribution
- 10846835011678 ()
FG170000
- Cardiac mapping system
No Description
Biosense Webster Inc
D129707
In Commercial Distribution
- 10846835009439 ()
D129707
- Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
D129704
In Commercial Distribution
- 10846835009422 ()
D129704
- Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
D128709
In Commercial Distribution
- 10846835008913 ()
D128709
- Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
D128627
Not in Commercial Distribution
- 10846835008906 ()
D128627
- Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
D128623
Not in Commercial Distribution
- 10846835008890 ()
D128623
- Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
D128622
In Commercial Distribution
- 10846835008883 ()
D128622
- Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CY1212CT
In Commercial Distribution
- 10846835003925 ()
CY1212CT
- Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CY1210CT
In Commercial Distribution
- 10846835003918 ()
CY1210CT
- Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CR3434CT
In Commercial Distribution
- 10846835003871 ()
CR3434CT
- Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CR3425CT
In Commercial Distribution
- 10846835003857 ()
CR3425CT
- Electrical-only medical device connection cable, reusable