Dome Electrodes

Primary DI
B618E0
Brand
Dome Electrodes
Company
COAPT LLC
Model
1
Device description
Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
Published
2019-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190416000Dome ElectrodeCoapt, LLC2019-04-04GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B618E0PrimaryHIBCC0
E10001Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeA non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078505297
Device count
18
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B618P1Gen2 System Kit12019-06-19
B618N1COMPLETE CONTROL System Gen212019-06-12
B618A0Complete Controller 1CC1102018-05-08
B618B0Complete Communicator 12018-05-08
B618C0Complete Co-Amp 12018-05-08
B618D0Complete Calibrate 12018-05-08
B618E1ControlSeal Electrode Domes (Standard Size)12023-01-09
B618E2ControlSeal Electrode Domes (Standard Size)12023-01-09
B618E4ControlSeal Electrode Domes (Standard Size)12023-02-20
B618E5ControlSeal Electrode Domes (Large Size)12023-02-20
E10001ControlSeal Electrode Domes (Standard Size)12023-01-09
B618E3ControlSeal Electrode Domes (Large Size)12023-01-09
E40001ControlSeal Electrode Domes (Standard Size)12023-02-20
E50001ControlSeal Electrode Domes (Large Size)12023-02-20
B618Q1Coapt Evaluation Kit12019-11-18

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