GUDID 00840682146890

GE Healthcare Austria GmbH & Co OG

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00840682146890
NIH Device Record Key4c281b88-73b2-4ffc-8683-41d76f89a3fe
Commercial Distribution StatusIn Commercial Distribution
Version Model NumbereM6C G3
Company DUNS300599979
Company NameGE Healthcare Austria GmbH & Co OG
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

Customer Support Contacts

Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx
Phone+1(800)437-1171
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682146890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-03
Device Publish Date2020-08-26

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00195278283375 - RIC10-D2023-10-19 RIC10-D
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00195278347497 - Voluson2022-06-22 Voluson Expert 22

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