FDA.reportPublic FDA data

Remote Control

Primary DI
17630039300989
Brand
Remote Control
Company
Bracco Injeneering SA
Model
102409
Catalog number
102409
Device description
"EmpowerCTA+ 17"" Remote 1731"
Published
2020-05-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IZQInjector, Contrast Medium, Automatic
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZQInjector, Contrast Medium, AutomaticCardiovascular2
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37630039300983PackageGS11Not in Commercial Distribution
17630039300989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3763003930098337630039300983
1763003930098917630039300989

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system control unitA mains electricity (AC-powered) electronic device that may be a component of a contrast medium injector system and designed to initiate and terminate the operation of a contrast medium injection procedure from a remote location (e.g., the shielded operators control room).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00dry environment

Regulatory Flags#

DUNS number
482489007
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
47630039302014EmpowerCTA+ Injector System017285, 0197752023-10-17
17630039302051Remote Control1024092024-05-29
37630039302048Remote Control1024092024-05-29
37630039300495EmpowerSync® Cables0173550173552016-09-20
47630039300812EmpowerCTA®+ Injector System with EDA0173830173832017-10-26
17630039300392Injector head 0173770173772016-09-20
17630039300477Remote Control1024091024092016-09-20
17630039300743Injector1024101024102016-09-20
17630039300767Remote Control (Onyx)1024091024092016-09-20
17630039300798Injector1024101024102017-10-26
17630039300910Injector Head1024102021-03-05
17630039301047Injector head1024102020-05-04
17630039301962Injector Head1024102024-04-26
17630039302037Injector Head1024102024-04-26
17630039301627FastLoad™ MR Syringe Pack 0173480173482024-04-08
17630039300385Hydraulic Controller0173780173782016-09-20
17630039300781Remote Control0173800173802016-09-20
17630039301726EDA Module Kit0173542020-05-05
47630039301000EmpowerCTA®+ Injector System0172852020-05-04
47630039300447EmpowerCTA®+ Injector System with EDA0173830173832016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDIZQ2026-05-06
08719326703824LungQ®Thirona B.V.JAK2026-02-12
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDIZQ2025-12-10
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDIZQ2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDIZQ2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDIZQ2025-03-28
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.JAK2025-03-03
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03