Accessory Kit 017381

GUDID 37630039300730

Bracco Injeneering SA

MRI contrast medium injection system, line-powered, mobile
Primary Device ID37630039300730
NIH Device Record Key8a2d1525-259b-47cb-89cb-abd40183519b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccessory Kit
Version Model Number017381
Catalog Number017381
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 Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment

Device Identifiers

Device Issuing AgencyDevice ID
GS137630039300730 [Primary]

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

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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