CT Exprès™ - Day Set III HP 640460

GUDID 37630039300020

Bracco Injeneering SA

Contrast medium injection system syringe
Primary Device ID37630039300020
NIH Device Record Key5ecd7f5f-7786-4722-ad5b-5e8e62b5cee2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT Exprès™ - Day Set III HP
Version Model Number640460
Catalog Number640460
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS117630039300026 [Primary]
GS137630039300020 [Package]
Contains: 17630039300026
Package: Box [15 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZQInjector, Contrast Medium, Automatic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-20
Device Publish Date2016-09-20

Devices Manufactured by Bracco Injeneering SA

37630039302048 - Remote Control2024-06-06 EmpowerCTA+ Injector System, Remote Control
17630039301962 - Injector Head2024-05-06
17630039302037 - Injector Head2024-05-06
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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