Pure EP PE-002-001-000

GUDID 00856750007000

PURE EP™ is a system 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 ID00856750007000
NIH Device Record Key45a8273d-662e-44cd-9b25-3cacc9f2929c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePure EP
Version Model NumberAE-0001-412
Catalog NumberPE-002-001-000
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100856750007000 [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 Date2021-05-13
Device Publish Date2021-05-05

On-Brand Devices [Pure EP]

08567500070008PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC)
00856750007000PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC)

Trademark Results [Pure EP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PURE EP
PURE EP
85617649 4893253 Live/Registered
BIOSIG TECHNOLOGIES, INC.
2012-05-04
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