FDA.reportPublic FDA data

Deymed Li-ion Battery

Primary DI
08592566453618
Brand
Deymed Li-ion Battery
Company
DEYMED Diagnostic s.r.o.
Model
3.7V 2500mAh 16650
Catalog number
45-361
Device description
Neurofeedback device accessories
Published
2023-10-26
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
08592566453618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592566453618085925664536188592566453618

GMDN Terms#

Term, Definition table
TermDefinition
Secondary batteryA rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The size, shape, and chemical composition of the battery should be specified according to the requirements of the appropriate IEC standard.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592566001093Pair of Ear Electrodes Sn (Tin)white, 1.5 m00-1092023-06-12
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
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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Primary DI, Brand, Company table
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00816271020377NoraxonNoraxon U.S.A., Inc.HCC2026-03-30
00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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00816271020438UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020445UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020452UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020469UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020476UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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00816271020490UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020506UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020513UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020520UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020735CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020766UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020773CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020889Ultium / CoreNoraxon U.S.A., Inc.HCC2026-03-30
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