Microstream Advance Adult Oral-Nasal CO2 Filter Line 989803204371

GUDID 20884838093700

Philips Medical Systems

Carbon-dioxide-sampling nasal oxygen cannula
Primary Device ID20884838093700
NIH Device Record Keyea98bf51-4361-4390-8a5f-2f030fb12b0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicrostream Advance Adult Oral-Nasal CO2 Filter Line
Version Model Number989803204371
Catalog Number989803204371
Company DUNS078628040
Company NamePhilips Medical Systems
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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 -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838093706 [Unit of Use]
GS120884838093700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-02
Device Publish Date2021-07-23

On-Brand Devices [Microstream Advance Adult Oral-Nasal CO2 Filter Line]

20884838093823989803204571
20884838093717989803204391
20884838093700989803204371
20884838093694989803204361
20884838091881989803204381
20884838091782989803204551

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