Heartrak ECAT 2

GUDID B147HTECAT020

Transmitters and Receivers, Electrocardiograph, Telephone

UNIVERSAL MEDICAL, INC.

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system
Primary Device IDB147HTECAT020
NIH Device Record Key975adbcd-a355-4080-b813-bfb3958bf0ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartrak ECAT 2
Version Model NumberHeartrak ECAT 2
Company DUNS803593073
Company NameUNIVERSAL MEDICAL, INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB147HTECAT020 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2017-01-21

Devices Manufactured by UNIVERSAL MEDICAL, INC.

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B147CBECAT0 - Heartrak ECAT Patient Cable2018-03-29 Electrode cable
B147CSS0 - Cardiostation Premier Stand Alone Software2018-03-29 Cardiostation Software sold with wireless devices.
B147CSTTM010 - Cardiostation Transtelephonic Module2018-03-29 Transmitters and Receivers, Electrocardiograph, Telephone
B147EC0 - eCardiostation Software2018-03-29 Software with CardioStation
B147FSAIR0 - Fusion Air2018-03-29 Transmitters and Receivers, Electrocardiograph, Telephone
B147HT20 - Heartrak 22018-03-29 Telephone electrocardiograph transmitter and receiver

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