FDA.report

N/A

Primary DI
EINO5901030
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
590103
Device description
ISIS MER complete system / Highline
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GZLElectrode, Depth

Product Code Classifications

CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EINO5901030PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
340782259
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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