ELI 380

GUDID 00812345026313

Electrocardiograph

MORTARA INSTRUMENT, INC.

Electrocardiograph, professional, multichannel
Primary Device ID00812345026313
NIH Device Record Keyec70762b-8aea-4aa6-ba06-51d06588f077
Commercial Distribution StatusIn Commercial Distribution
Brand NameELI 380
Version Model NumberELI380-ACS11
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
GS100812345026313 [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 Date2016-09-24

On-Brand Devices [ELI 380]

00812345027020Electrocardiograph
00812345027013Electrocardiograph
00812345027006Electrocardiograph
00812345026993Electrocardiograph
00812345026986Electrocardiograph
00812345026979Electrocardiograph
00812345026962Electrocardiograph
00812345026955Electrocardiograph
00812345026948Electrocardiograph
00812345026931Electrocardiograph
00812345026924Electrocardiograph
00812345026917Electrocardiograph
00812345026900Electrocardiograph
00812345026894Electrocardiograph
00812345026887Electrocardiograph
00812345026870Electrocardiograph
00812345026863Electrocardiograph
00812345026856Electrocardiograph
00812345026849Electrocardiograph
00812345026832Electrocardiograph
00812345026825Electrocardiograph
00812345026818Electrocardiograph
00812345026801Electrocardiograph
00812345026795Electrocardiograph
00812345026788Electrocardiograph
00812345026771Electrocardiograph
00812345026764Electrocardiograph
00812345026757Electrocardiograph
00812345026740Electrocardiograph
00812345026733Electrocardiograph
00812345026726Electrocardiograph
00812345026719Electrocardiograph
00812345026702Electrocardiograph
00812345026696Electrocardiograph
00812345026689Electrocardiograph
00812345026672Electrocardiograph
00812345026665Electrocardiograph
00812345026658Electrocardiograph
00812345026641Electrocardiograph
00812345026634Electrocardiograph
00812345026627Electrocardiograph
00812345026610Electrocardiograph
00812345026603Electrocardiograph
00812345026597Electrocardiograph
00812345026580Electrocardiograph
00812345026573Electrocardiograph
00812345026566Electrocardiograph
00812345026559Electrocardiograph
00812345026542Electrocardiograph
00812345026535Electrocardiograph

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