AM12M

GUDID 00812345029666

Wired Acquisition System cleared with Surveyor S12/S19 Monitor

MORTARA INSTRUMENT, INC.

Electrocardiographic lead set, reusable
Primary Device ID00812345029666
NIH Device Record Keya3552b31-b3dd-4211-a720-85bca9fb151f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAM12M
Version Model Number41000-037-50
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
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
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
GS100812345029666 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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 [AM12M]

00812345029710Wired Acquisition System cleared with Surveyor S12/S19 Monitor
00812345029673Wired Acquisition System cleared with Surveyor S12/S19 Monitor
00812345029666Wired Acquisition System cleared with Surveyor S12/S19 Monitor

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