FDA.reportPublic FDA data

Pair of Ear Electrodes Sn (Tin)

Primary DI
08592566001093
Brand
Pair of Ear Electrodes Sn (Tin)
Company
DEYMED Diagnostic s.r.o.
Model
white, 1.5 m
Catalog number
00-109
Device description
Neurofeedback device accessories
Published
2023-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592566001093PrimaryGS10
08592566639005Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592566001093085925660010938592566001093
08592566639005085925666390058592566639005

GMDN Terms#

Term, Definition table
TermDefinition
Psychophysiological biofeedback systemA computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-375-8353sales@ronanmedical.com

Regulatory Flags#

DUNS number
495566056
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592566001109Pair of Ear Electrodes Sn (Tin)white, 15 cm00-1102023-06-12
08592566001116Pair of Ear Electrodes Sn (Tin)blue, 1.5 m00-1112023-06-12
08592566001208Disposable blunted needles50 pcs00-1202023-10-26
08592566419003TruScan Neurofeedback Adapter41-90041-9002023-10-26
08592566431395TruScan LT 24 Neurofeedback headbox43-13943-1392023-10-26
08592566432392TruScan LT 32 Neurofeedback headbox43-23943-2392023-10-26
08592566449000TruScan Neurofeedback optical cable V3.3L44-90044-9002023-10-26
08592566453618Deymed Li-ion Battery3.7V 2500mAh 1665045-3612023-10-26
08592566509001TruScan Neurofeedback Acquisition50-90050-9002023-10-26
08592566509506TruScan Neurofeedback Explorer50-95050-9502023-10-26
08592566639005Ear Electrode Sn (Tin)white, 1.5 m63-9002023-10-26
08592566639012Ear Electrode Sn (Tin)white, 15 cm63-9012023-10-26
08592566639029Ear Electrode Sn (Tin)blue, 1.5 m63-9022023-10-26
08592566639234Headbox Safety Ribbon Cable for Cap Connection50cm63-9232023-10-26
08592566639340EEG cap strapXS (green)63-9342023-10-26
08592566639357EEG cap strapS (yellow)63-9352023-10-26
08592566639364EEG cap strapM (red)63-9362023-10-26
08592566639371EEG cap strapL (blue)63-9372023-10-26
08592566679001FlexiCAP electrode ring - rubberwhite67-9002023-10-26
08592566829109FlexiCAPSize XS 47-51 cm, 18,5-20 in, layout 0682-9102023-10-26

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