FDA.reportPublic FDA data

Pure EP - 5 x 10 pin Yoked Jumper Cable White

Primary DI
00856750007130
Brand
Pure EP - 5 x 10 pin Yoked Jumper Cable White
Company
BIOSIG TECHNOLOGIES, INC.
Model
PE-002-019-005
Catalog number
PE-002-019-005
Device description
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 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 highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
Published
2022-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180805000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180805000Pure EPBiosig Technologies2018-08-08DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856750007130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856750007130008567500071308567500071300856750007130

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology analysis systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-203-409-5444eriechert@biosigtech.com

Regulatory Flags#

DUNS number
080048456
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08567500070008Pure EPAE-0001-412AE-0001-4122021-01-20
00856750007093Pure EP - 5 x Single Jumper Cable Red 0.3mPE-002-013-005PE-002-013-0052022-02-07
00856750007109Pure EP - 5 x Single Jumper Cable Black 0.3mPE-002-014-005PE-002-014-0052022-02-07
00856750007116Pure EP - 5 x Single Jumper Cable Black 0.1mPE-002-017-005PE-002-017-0052022-02-07
00856750007147Pure EP - 5 x 10 pin Yoked Jumper Cable BluePE-002-020-005PE-002-020-0052022-02-07
00856750007154Pure EP - 5 x 10 pin Yoked Jumper Cable GreenPE-002-018-005PE-002-018-0052022-02-07
00856750007161Pure EP - 5 x 4 pin Yoked Jumper Cable YellowPE-002-015-005PE-002-015-0052022-02-07
00856750007178Pure EP - 5 x 4 pin Yoked Jumper Cable RedPE-002-016-005PE-002-016-0052022-02-07
00856750007031Pure EP - Catheter Input ModulePE-002-006-000PE-002-006-0002021-06-30
00856750007048Pure EP - Catheter Input ModulePE-002-007-000PE-002-007-0002021-06-30
00856750007055Pure EP - ECG Cable PE-002-008-000PE-002-008-0002021-06-30
00856750007123Pure EP - Dual ECG Splitter BoxPE-002-021-000PE-002-021-0002021-05-12
00856750007000Pure EPAE-0001-412PE-002-001-0002021-05-05

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