FDA.reportPublic FDA data

MRI ECG Cable

Primary DI
00816396023246
Brand
MRI ECG Cable
Company
IVY BIOMEDICAL SYSTEMS, INC.
Model
4190-01-01
Device description
MRI ECG Cable
Published
2022-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816396023246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816396023246008163960232468163960232460816396023246

GMDN Terms#

Term, Definition table
TermDefinition
MRI system synchronizerA physiological monitoring unit used as a component of a diagnostic magnetic resonance imaging (MRI) system, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic MRI applications. It is sometimes referred to as a gated imaging accessory or trigger.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length72Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-481-4183sales@ivybiomedical.com

Regulatory Flags#

DUNS number
109132019
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816396022553ECG Patient Cable5904825904822023-06-08
00816396022560ECG Patient Cable5904795904792023-06-08
00816396022577ECG Patient Cable5904805904802023-06-08
00816396022706ECG Patient Cable5904775904772023-06-08
00816396022713ECG Patient Cable5904785904782023-06-08
00816396022812ECG Trunk Cable5904765904762023-06-08
00816396022829ECG Patient Cable5904815904812023-06-08
00816396022836ECG Lead Wires5904915904912023-06-08
00816396022843ECG Lead Wires5904895904892023-06-08
00816396022850ECG Lead Wires5904905904902023-06-08
00816396022911ECG Trunk Cable5904925904922023-06-08
00816396021570ECG Patient Cable5904065904062016-09-01
00816396021587ECG Lead Wires5904075904072016-09-01
00816396021594ECG Patient Cable5904085904082016-09-01
00816396021600ECG Lead Wires5904095904092016-09-01
00816396021617ECG Patient Cable5904105904102016-09-01
00816396021624ECG Lead Wires5904115904112016-09-01
00816396021631ECG Patient Cable5904125904122016-09-01
00816396021648ECG Lead Wires5904135904132016-09-01
00816396021655ECG Snap Lead Wires5904145904142016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.MWI2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
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