ELI 150c

GUDID 00817655020402

Electrocardiograph

MORTARA INSTRUMENT, INC.

Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel
Primary Device ID00817655020402
NIH Device Record Key572bbd53-a7a5-4684-8f1f-b7b9ba2b83e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameELI 150c
Version Model NumberELI150c-GAB-AFHAB
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 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

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817655020402 [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 Number5
Public Version Date2020-06-29
Device Publish Date2016-10-17

On-Brand Devices [ELI 150c]

00812345029956Electrocardiograph
00812345029789Electrocardiograph
00812345027303Electrocardiograph
00812345026351Electrocardiograph
00812345026344Electrocardiograph
00812345026337Electrocardiograph
00812345025774Electrocardiograph
00812345025699Electrocardiograph
00812345025675Electrocardiograph
00812345025651Electrocardiograph
00812345025637Electrocardiograph
00812345025613Electrocardiograph
00812345025477Electrocardiograph
00812345025453Electrocardiograph
00812345025439Electrocardiograph
00812345025415Electrocardiograph
00812345025408Electrocardiograph
00812345025392Electrocardiograph
00812345025378Electrocardiograph
00812345025354Electrocardiograph
00812345025330Electrocardiograph
00812345025316Electrocardiograph
00812345025293Electrocardiograph
00812345025088Electrocardiograph
00812345025071Electrocardiograph
00812345025019Electrocardiograph
00817655023144Electrocardiograph
00817655023007Electrocardiograph
00817655022994Electrocardiograph
00817655022987Electrocardiograph
00817655022659Electrocardiograph
00817655022123Electrocardiograph
00817655021867Electrocardiograph
00817655021843Electrocardiograph
00817655021805Electrocardiograph
00817655021768Electrocardiograph
00817655021751Electrocardiograph
00817655021393Electrocardiograph
00817655021317Electrocardiograph
00817655020921Electrocardiograph
00817655020747Electrocardiograph
00817655020631Electrocardiograph
00817655020464Electrocardiograph
00817655020402Electrocardiograph
00817655020341Electrocardiograph
00817655020327Electrocardiograph
00817655020211Electrocardiograph

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