ELI Edit

GUDID 00817655022802

Cardiology Data Software

MORTARA INSTRUMENT, INC.

Patient health record information system
Primary Device ID00817655022802
NIH Device Record Key830be1d8-1fb1-4704-9890-3a56d51f3345
Commercial Distribution StatusIn Commercial Distribution
Brand NameELI Edit
Version Model Number11049-011-51
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
GS100817655022802 [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 Date2017-12-13

On-Brand Devices [ELI Edit]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.