FilterLine / Microstream 989803179121

GUDID 20884838071142

Philips Medical Systems

Carbon-dioxide-sampling nasal oxygen cannula
Primary Device ID20884838071142
NIH Device Record Key19ddc984-0614-44df-89f6-531ac8ddac4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFilterLine / Microstream
Version Model Number989803179121
Catalog Number989803179121
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 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 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838071148 [Unit of Use]
GS120884838071142 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-23

On-Brand Devices [FilterLine / Microstream]

20884838071166989803182921
20884838071159989803182911
20884838071142989803179121
20884838071135989803179111
20884838071128989803179101
20884838071111989803178021
20884838071173989803182931

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