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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