Adhesive Solid Gel Electrodes (pack of 100)

GUDID 40857175006096

Resting EKG Tab Electrodes inner pack of 100

VECTRACOR INC

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use
Primary Device ID40857175006096
NIH Device Record Key44823e47-9322-457c-a3c7-25ffcb2b1da1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdhesive Solid Gel Electrodes (pack of 100)
Version Model NumberZ-5000-1920
Company DUNS828416359
Company NameVECTRACOR INC
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857175006098 [Unit of Use]
GS100857175006142 [Package]
Contains: 50857175006093
Package: Case of 4000 [4 Units]
In Commercial Distribution
GS140857175006096 [Primary]
GS150857175006093 [Package]
Package: Inner case of 1000 [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

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40857175006096 - Adhesive Solid Gel Electrodes (pack of 100)2018-07-06Resting EKG Tab Electrodes inner pack of 100
40857175006096 - Adhesive Solid Gel Electrodes (pack of 100)2018-07-06 Resting EKG Tab Electrodes inner pack of 100
00857175006012 - Vectraplex CMS2018-07-06 Vectraplex Central Monitoring System
00857175006029 - VectraplexECG System2018-07-06 VectraplexECG System with Cardio Electrical Bio-marker (CEB)
00857175006043 - Universal ECG2018-07-06 ECG Amplifier
00857175006050 - Orbit Spirometer2018-07-06 Orbit Spirometer

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