Fast-Fix ECG Electrode

GUDID 06430035220335

The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixed to the patient's che

Mega Elektroniikka Oy

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Primary Device ID06430035220335
NIH Device Record Key79f8bd3f-54c4-46a3-8ce0-db3473872b86
Commercial Distribution StatusIn Commercial Distribution
Brand NameFast-Fix ECG Electrode
Version Model Number901155
Company DUNS369960000
Company NameMega Elektroniikka Oy
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com
Phone+358400541179
Emailbbs@bittium.com

Device Identifiers

Device Issuing AgencyDevice ID
GS106430035220335 [Primary]

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-06
Device Publish Date2018-07-04

Devices Manufactured by Mega Elektroniikka Oy

06430035220366 - Bittium Faros2019-11-08 Device for 3-channel ECG and motion measurement, monitoring and data collection
06430035220311 - Faros 360 waterproof2019-11-08 Device for 3-channel ECG and motion measurement, monitoring and data collection.
06430035220335 - Fast-Fix ECG Electrode2018-08-06The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixed to the patient's che
06430035220335 - Fast-Fix ECG Electrode2018-08-06 The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixe
06430035220014 - FemiScan2018-07-06 FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscles by using EMG-signals.
06430035220021 - FemiScan2018-07-06 Electrode for FemiScan HomeTrainer (HTCS) device. For single patient use.
06430035220151 - Faros2018-07-06 Device for 1-channel ECG and motion measurement and data collection
06430035220168 - Faros2018-07-06 Device for 1-channel ECG and motion measurement, monitoring and data collection
06430035220175 - Faros2018-07-06 Device for 3-channel ECG and motion measurement, monitoring and data collection

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