989803100491

GUDID 20884838000876

Philips Medical Systems

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 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 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 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 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 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 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 ID20884838000876
NIH Device Record Keye31bb0e6-a9ab-4f8d-80ab-606ed3b85f56
Commercial Distribution StatusIn Commercial Distribution
Version Model Number989803100491
Catalog Number989803100491
Company DUNS078628040
Company NamePhilips Medical Systems
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
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Emailxx@xx.xx
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Emailxx@xx.xx
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Emailxx@xx.xx
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Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
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Phone+1(999)999-9999
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Phone+1(999)999-9999
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Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
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Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
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Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx

Operating and Storage Conditions

Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 89.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110884838000879 [Unit of Use]
GS120884838000876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRXElectrode, electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-03

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