FDA.reportPublic FDA data

Premier Heart Reusable Limb Clip Electrodes

Primary DI
B320LCA20
Brand
Premier Heart Reusable Limb Clip Electrodes
Company
PREMIER HEART, LLC
Model
LCA2
Device description
Reusable Limb Clip Electrodes, Large, EU/IEC Lead Colors
Published
2024-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B320LCA20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, reusableA noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
109797584
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B320MCGS0Premier Heart MCG Analysis APIMCGS2024-05-03
B320CF190Premier Heart MCGCF19CF192016-09-27
B320MCGC0Premier Heart MCG Analysis SoftwareMCGC2018-05-17
B320LCA00Premier Heart Reusable Limb Clip ElectrodesLCA02024-05-06
B320LCA10Premier Heart Reusable Limb Clip ElectrodesLCA12024-05-06
B320VH120Premier Heart MCG Model VH12VH122018-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060038511034Ambu® WhiteSensor 40554Ambu A/SDRX2026-08-07
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G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
10841522130298Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCDRX2023-02-23
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
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