FDA.reportPublic FDA data

ECG Lead Wires

Primary DI
00816396022348
Brand
ECG Lead Wires
Company
IVY BIOMEDICAL SYSTEMS, INC.
Model
590319
Catalog number
590319
Device description
ECG Lead Wires, Radiotranslucent, 3 Lead Set, AHA, 36 in
Published
2018-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970755000STEALTHSHIELDVital Connections, Inc.1997-04-15DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816396022348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816396022348008163960223488163960223480816396022348

GMDN Terms#

Term, Definition table
TermDefinition
Radiolucent electrocardiographic leadA radiolucent insulated metal or non-metallic wire(s) with an electrode used to conduct electrical signals from a patient's heart, via the electrode which is attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine. It is typically used during cardiac catheterization procedures because it will cast a slight or negligible shadow on the radiographic images. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length36Inch

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

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

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Primary DI, Brand, Company table
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G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
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