Heartrak Smart Rev 5

GUDID B147HTSM50

Transmitters and Receivers, Electrocardiograph, Telephone

UNIVERSAL MEDICAL, INC.

Electrocardiography telemetric monitoring system
Primary Device IDB147HTSM50
NIH Device Record Key4187e61b-a873-4529-ad5e-9441a5572eae
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartrak Smart Rev 5
Version Model NumberHeartrak Smart Rev 5
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
HIBCCB147HTSM50 [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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