989803172131

GUDID 20884838013517

Philips Medical Systems

Electrocardiographic lead set, reusable
Primary Device ID20884838013517
NIH Device Record Key84b8b3c1-4648-4793-8215-9aa918674356
Commercial Distribution StatusIn Commercial Distribution
Version Model Number989803172131
Catalog Number989803172131
Company DUNS078628040
Company NamePhilips Medical Systems
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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 -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838013513 [Unit of Use]
GS120884838013517 [Primary]

FDA Product Code

DSIDETECTOR AND ALARM, ARRHYTHMIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-10-01
Device Publish Date2020-03-25

Devices Manufactured by Philips Medical Systems

10884838000671 - Paper2021-11-18
00884838107199 - PageWriter2021-10-15
20884838013517 - NA2021-10-01
20884838013517 - NA2021-10-01
20884838013524 - NA2021-10-01
20884838091782 - Microstream Advance Adult Oral-Nasal CO2 Filter Line2021-08-02
20884838091829 - Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line2021-08-02
20884838091836 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line2021-08-02
20884838091850 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line2021-08-02

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