989803100541

GUDID 20884838006786

Philips Medical Systems

Electrocardiographic electrode, single-use
Primary Device ID20884838006786
NIH Device Record Keye4fd8231-dd5a-4319-b35a-114c43364fa7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number989803100541
Catalog Number989803100541
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

Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110884838006789 [Unit of Use]
GS120884838006786 [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 Date2017-01-03

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