865352

GUDID 00884838030350

Philips Medical Systems

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor
Primary Device ID00884838030350
NIH Device Record Keyd3afb4e4-4622-4509-9ed2-38aa9ac46123
Commercial Distribution StatusIn Commercial Distribution
Version Model Number865352
Catalog Number865352
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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

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
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
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
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
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
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
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
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
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
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
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
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
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838030350 [Primary]

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-06
Device Publish Date2016-09-22

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.