ELI Edit

GUDID 00812345025217

Cardiology Data Software

MORTARA INSTRUMENT, INC.

Patient health record information system
Primary Device ID00812345025217
NIH Device Record Keyf8e15c21-641e-4c4c-9c9f-73237b86a5f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameELI Edit
Version Model Number11049-010-51
Company DUNS062046149
Company NameMORTARA INSTRUMENT, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812345025217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-29
Device Publish Date2016-09-24

On-Brand Devices [ELI Edit]

00812345025217Cardiology Data Software
00812345023459Cardiology Data Software
00817655022802Cardiology Data Software
00817655022796Cardiology Data Software

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