TOTALTRACE 3700-003

GUDID 30845854051218

Totaltrace Adult General Purpose Foam ECG Electrode

Conmed Corporation

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use
Primary Device ID30845854051218
NIH Device Record Keyc99d9a04-12e0-41cd-b6a0-6e44373d5381
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOTALTRACE
Version Model Number3700-003
Catalog Number3700-003
Company DUNS071595540
Company NameConmed Corporation
Device Count600
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com

Operating and Storage Conditions

Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100845854051217 [Unit of Use]
GS110845854051214 [Primary]
GS130845854051218 [Package]
Contains: 10845854051214
Package: CASE [600 Units]
In Commercial Distribution

FDA Product Code

DRXElectrode, electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-06
Device Publish Date2020-01-29

On-Brand Devices [TOTALTRACE]

30845854051331Totaltrace Adult General Purpose Foam ECG Electrode
30845854051324Totaltrace Adult General Purpose Foam ECG Electrode
30845854051256Totaltrace Adult General Purpose Foam ECG Electrode
30845854051249Totaltrace Adult General Purpose Foam ECG Electrode
30845854051232Totaltrace Adult General Purpose Foam ECG Electrode
30845854051225Totaltrace Adult General Purpose Foam ECG Electrode
30845854051218Totaltrace Adult General Purpose Foam ECG Electrode
30845854051201Totaltrace Adult General Purpose Foam ECG Electrode

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