Pure EP - Dual ECG Splitter Box PE-002-021-000

GUDID 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, 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.

Cardiac electrophysiology analysis system
Primary Device ID00856750007123
NIH Device Record Key9d480211-9a65-469b-b2ab-f4da7d17f53d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePure EP - Dual ECG Splitter Box
Version Model NumberPE-002-021-000
Catalog NumberPE-002-021-000
Company DUNS080048456
Company NameBIOSIG TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com
Phone1-203-409-5444
Emaileriechert@biosigtech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856750007123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-20
Device Publish Date2021-05-12

Devices Manufactured by BIOSIG TECHNOLOGIES, INC.

00856750007093 - Pure EP - 5 x Single Jumper Cable Red 0.3m2022-02-15 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 Sy
00856750007109 - Pure EP - 5 x Single Jumper Cable Black 0.3m2022-02-15 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
00856750007116 - Pure EP - 5 x Single Jumper Cable Black 0.1m2022-02-15 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
00856750007130 - Pure EP - 5 x 10 pin Yoked Jumper Cable White2022-02-15 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 P
00856750007147 - Pure EP - 5 x 10 pin Yoked Jumper Cable Blue2022-02-15 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 PUR
00856750007154 - Pure EP - 5 x 10 pin Yoked Jumper Cable Green2022-02-15 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 PU
00856750007161 - Pure EP - 5 x 4 pin Yoked Jumper Cable Yellow2022-02-15 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 PU
00856750007178 - Pure EP - 5 x 4 pin Yoked Jumper Cable Red2022-02-15 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
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