FDA.reportPublic FDA data

Remote Control

Primary DI
17630039300477
Brand
Remote Control
Company
Bracco Injeneering SA
Model
102409
Catalog number
102409
Device description
"EmpowerCTA+ 17"" Remote 1722"
Published
2016-09-20
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
DSBPlethysmograph, Impedance
IZQInjector, Contrast Medium, Automatic
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2
IZQInjector, Contrast Medium, AutomaticCardiovascular2
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37630039300471PackageGS11Not in Commercial Distribution
17630039300477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3763003930047137630039300471
1763003930047717630039300477

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
17630039300743Injector1024101024102016-09-20
17630039300767Remote Control (Onyx)1024091024092016-09-20
17630039300798Injector1024101024102017-10-26
17630039300910Injector Head1024102021-03-05
17630039300989Remote Control1024091024092020-05-04
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

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10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
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