989803101501

GUDID 00884838001121

Philips Medical Systems

Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper Electrocardiographic recording paper
Primary Device ID00884838001121
NIH Device Record Keyd84e451a-d3d1-4ece-b243-65af353d748b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number989803101501
Catalog Number989803101501
Company DUNS078628040
Company NamePhilips Medical Systems
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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 Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
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Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838001121 [Primary]
GS110884838001128 [Unit of Use]

FDA Product Code

DSFRECORDER, PAPER CHART

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-07
Device Publish Date2019-07-30

Devices Manufactured by Philips Medical Systems

10884838000671 - Paper2021-11-18
00884838107199 - PageWriter2021-10-15
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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