Cardiospy ECG Holter System

GUDID 05999883490013

The battery powered Cardiospy ECG Holter System provides 1, 2, 3 channel recordings, depending on the recorder and patient cable type being used. The

LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság

Electrocardiographic long-term ambulatory recording analyser
Primary Device ID05999883490013
NIH Device Record Key41b745c0-1583-4792-8e10-c8acb148dd9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardiospy ECG Holter System
Version Model NumberEC-3H
Company DUNS520963286
Company NameLABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+19496796100
Emailsmerritt@cercacor.com

Device Dimensions

Weight50 Gram
Width18.5 Millimeter
Width53 Millimeter
Length67.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105999883490013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

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 Date2017-12-06

On-Brand Devices [Cardiospy ECG Holter System]

05999883490075The USB-02 Dongle is the hardware key for Cardiospy software that makes possible the use of Card
05999883490044The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depe
05999883490013The battery powered Cardiospy ECG Holter System provides 1, 2, 3 channel recordings, depending o
05999883490006The battery powered Cardiospy ECG Holter System provides 1, 2 channel recordings, depending on t

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