Pure EP - ECG Cable PE-002-008-000

GUDID 00856750007055

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.

Cardiac electrophysiology analysis system

• Primary Device ID: 00856750007055
• NIH Device Record Key: a93a4d76-7d3a-4b3d-9f6f-156abcc2d7f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure EP - ECG Cable
• Version Model Number: PE-002-008-000
• Catalog Number: PE-002-008-000
• Company DUNS: 080048456
• Company Name: BIOSIG TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856750007055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180805

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-08
• Device Publish Date: 2021-06-30

Devices Manufactured by BIOSIG TECHNOLOGIES, INC.

• 00856750007093 - Pure EP - 5 x Single Jumper Cable Red 0.3m: 2022-02-15 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 0.3m: 2022-02-15 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 0.1m: 2022-02-15 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 White: 2022-02-15 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 Blue: 2022-02-15 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 Green: 2022-02-15 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 Yellow: 2022-02-15 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 Red: 2022-02-15 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