CloudEKG

GUDID 04650075330081

The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for card

NEUROSOFT, OOO

Electrocardiography telemetric monitoring system
Primary Device ID04650075330081
NIH Device Record Keyb6ead905-1926-4578-b039-019231725b2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCloudEKG
Version Model NumberCloudEKG
Company DUNS643212926
Company NameNEUROSOFT, OOO
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104650075330081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXHTransmitters And Receivers, Electrocardiograph, Telephone

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 Date2016-09-21

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