FDA.reportPublic FDA data

N/A

Primary DI
EINO5083000
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
508300
Device description
Trolley for C2 NerveMonitor
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve
GWFStimulator, Electrical, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GWFStimulator, Electrical, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EINO5083000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-function monitorA mains electricity (AC-powered) bedside device designed to continuously assess the adequacy of the nerve function of a non-ambulatory patient who requires monitoring (e.g., as a result of trauma, anaesthesia, intervention, evaluation). It typically monitors evoked potential (EP), electromyography (EMG), electroencephalography (EEG) and/or neuromuscular block response. It typically consists of electrodes applied to the patient intended to acquire the neural electrical signal, and a computerized unit to process and display the information; stimulation systems for nerve block and evoked potential evaluation are separate requirements.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
340782259
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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