FDA.reportPublic FDA data

Extravasation Detection Patch with Access Slot

Primary DI
17630039300347
Brand
Extravasation Detection Patch with Access Slot
Company
Bracco Injeneering SA
Model
017352
Catalog number
017352
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
27630039300344PackageGS125In Commercial Distribution
37630039300341PackageGS150In Commercial Distribution
17630039300347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2763003930034427630039300344
3763003930034137630039300341
1763003930034717630039300347

GMDN Terms#

Term, Definition table
TermDefinition
Neoplasm electrical impedance spectrometer electrode arrayA non-sterile arrangement of multiple electrical conductors intended to be used in conjunction with an electrical impedance spectrometer (EIS) to apply a small electric current to the skin during EIS analysis of neoplastic skin. It is typically a small cover that fits over a probe and may be textured (e.g., with pins) to penetrate the outermost layer of skin. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dry Environment

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41216236030maud.giorgi@bracco.com

Regulatory Flags#

DUNS number
482489007
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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
08719327007136FinapresFinapres Medical Systems B.V.DSB2026-10-21
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.JAK2026-10-19
03760305400246DUAL SIDED NEEDLE GUIDEQUANTUM SURGICALJAK2026-10-19
03760305400277PATIENT REFERENCE 2.0QUANTUM SURGICALJAK2026-10-19
19356870000045CAC4DMEDICAL LIMITEDJAK2026-10-13
19356870000090LDA4DMEDICAL LIMITEDJAK2026-10-13
00860016243804C-beamPulmera, Inc.JAK2026-10-10
00884838120433SmartCTPhilips Medical Systems Nederland B.V.JAK2026-09-28
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-09-21
00860015781925Bunkerhill Contrast AVCBunkerhill Health Inc.JAK2026-09-16
00884838129559CT Areta RT/Rembra RT UpgradesPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-08-21
00885403523437HemoSphere AltaBecton, Dickinson And CompanyDSB2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyDSB2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyDSB2026-08-06
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00860015781901CAC (Gated) AlgorithmBunkerhill Health Inc.JAK2026-05-13
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00198953085950PhotonovaGE Medical Systems, L.L.C.JAK2026-05-11
00884838129528CT RembraPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00884838129535CT Rembra RTPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00884838129542CT Areta RTPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03