Azurion 722230

GUDID 00884838116733

Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat detector

Philips Medical Systems Nederland B.V.

Stationary angiographic x-ray system, digital
Primary Device ID00884838116733
NIH Device Record Keyf4904e08-dd0a-428f-8ab7-4082f0c35d82
Commercial Distribution StatusIn Commercial Distribution
Brand NameAzurion
Version Model NumberAzurion 3 M15
Catalog Number722230
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838116733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, x-ray, fluoroscopic, image-intensified

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-06
Device Publish Date2023-08-29

On-Brand Devices [Azurion]

00884838085367Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ce
00884838085350Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ce
00884838085282Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat det
00884838085275Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat det
00884838085268Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
00884838085251Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc
00884838116740Monoplane Interventional X-Ray System. A ceiling monoplane system with a 12-inch flat detector.
00884838116733Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat dete
00884838116726Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat dete
00884838116801Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ce
00884838116788Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ce
00884838116771Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
00884838116764Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc
00884838116757Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
00884838099272Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ce
00884838099265Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ce
00884838099258Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
00884838099241Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc
00884838099234Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
00884838099227Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc
00884838099210Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat det
00884838099203Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat det

Trademark Results [Azurion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AZURION
AZURION
79162838 5051661 Live/Registered
KONINKLIJKE PHILIPS N.V.
2015-03-04

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