| Primary Device ID | 00856750007116 |
| NIH Device Record Key | 93779f13-d489-4c74-88c5-f880ac51eae0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pure EP - 5 x Single Jumper Cable Black 0.1m |
| Version Model Number | PE-002-017-005 |
| Catalog Number | PE-002-017-005 |
| 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 |
| 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 | 2022-02-155 cables in one bag with single jumper cables black 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. |
| 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 |