Collimator ML01 II

GUDID 04056869011554

Siemens Healthcare GmbH

Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized Manual-aperture-control diagnostic x-ray system collimator, motorized
Primary Device ID04056869011554
NIH Device Record Key5f613553-a414-4cfb-947c-ccc98361dac1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCollimator ML01 II
Version Model Number10092611
Company DUNS313217003
Company NameSiemens Healthcare GmbH
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 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

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
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(999)999-9999
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104056869011554 [Primary]

FDA Product Code

KPWDevice, beam limiting, x-ray, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-02-02

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