FDA.reportPublic FDA data

EDA Module Kit

Primary DI
37630039301720
Brand
EDA Module Kit
Company
Bracco Injeneering SA
Model
017354
Published
2020-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DSBPlethysmograph, Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37630039301720PackageGS11In Commercial Distribution
17630039300422PreviousGS10
17630039301726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3763003930172037630039301720
1763003930042217630039300422
1763003930172617630039301726

GMDN Terms#

Term, Definition table
TermDefinition
CT contrast medium injection system, line-powered, stationaryAn assembly of devices designed to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). It consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for CT studies, and is stationary (e.g., fixed to a room rack). The system may synchronize media delivery with the x-ray generator during CT scanning.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
482489007
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2026-06-03
04260451441180Osypka MedicalOsypka Medical GmbHDSB2026-04-24
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDSB2026-03-16
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCDSB2025-09-10
00690103219531Acumen IQ PlusEdwards Lifesciences LLCDSB2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCDSB2025-09-10
B719G73C0Valhalla Scientific, IncValhalla ScientificDSB2025-07-28
00690103219616ForeSight IQEdwards Lifesciences LLCDSB2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCDSB2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCDSB2025-07-11
00690103217957HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DSB2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DSB2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DSB2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DSB2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DSB2025-03-13
00690103218879HemoSphere VitaEdwards Lifesciences LLCDSB2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCDSB2024-08-28
B719G62J0Valhalla Scientific, IncValhalla ScientificDSB2024-06-17
B719G63C0Valhalla Scientific, IncValhalla ScientificDSB2024-04-12
B719BE3B0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G61S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G62Q0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G62S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15