AccessGUDID - DEVICE: Pure EP - Dual ECG Splitter Box (00856750007123)

GUDID

Device Identifier (DI) Information

Brand Name: Pure EP - Dual ECG Splitter Box
Version or Model: PE-002-021-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PE-002-021-000
Company Name: BIOSIG TECHNOLOGIES, INC.

Primary DI Number: 00856750007123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080048456 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17898	Cardiac electrophysiology analysis system	An assembly of devices designed to perform several diagnostic tests and therapeutic treatments of the heart in patients with arrhythmic or conduction disorders. It typically consists of a computerized workstation including a monitor, a printer or graphic recorder, a data recorder (e.g., optical or magnetic disk), and plug-in modules for signal amplification and/or conditioning. Signals are taken from external electrodes on the chest as well as from intracardiac electrodes and from blood pressure transducers. Device uses include analysis of the atrioventricular conduction system, defibrillator function, and the induction/termination of ventricular tachycardia.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	Computer, Diagnostic, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180805	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9d480211-9a65-469b-b2ab-f4da7d17f53d
Public Version Date: June 15, 2021
Public Version Number: 2
DI Record Publish Date: May 12, 2021