989803100441

GUDID 20884838000852

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
Primary Device ID20884838000852
NIH Device Record Keycb3d0633-5c34-406f-97de-16814de73eee
Commercial Distribution StatusIn Commercial Distribution
Version Model Number989803100441
Catalog Number989803100441
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

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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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 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 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS120884838000852 [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 Date2016-12-27

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