CT Exprès™ - Control Panel 650197

GUDID 37630039300112

Bracco Injeneering SA

Contrast medium injection system control unit
Primary Device ID37630039300112
NIH Device Record Keycac761bd-94f8-47bc-9baa-4b0a295574b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT Exprès™ - Control Panel
Version Model Number650197
Catalog Number650197
Company DUNS482489007
Company NameBracco Injeneering SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41216236030
Emailmaud.giorgi@bracco.com
Phone+41216236030
Emailmaud.giorgi@bracco.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS117630039300118 [Primary]
GS137630039300112 [Package]
Contains: 17630039300118
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZQInjector, Contrast Medium, Automatic

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 Date2016-09-20

Devices Manufactured by Bracco Injeneering SA

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17630039301627 - FastLoad™ MR Syringe Pack 2024-04-16
37630039301980 - IV Pole2024-03-11
37630039301997 - Floor Stand2024-03-11
47630039301949 - EmpowerCTA+ Injector System2024-02-13 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
47630039302014 - EmpowerCTA+ Injector System2023-10-25 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector

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