FDA.reportPublic FDA data

Minder® Implant

Primary DI
00840336500085
Brand
Minder® Implant
Company
EPIMINDER LIMITED
Model
P1650482
Catalog number
P1650482
Device description
Implant G0-R1
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SEMSub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SEMSub-Scalp Implanted Electroencephalogram System For Remote Patient MonitoringNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840336500085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840336500085008403365000858403365000850840336500085

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring systemAn electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744517398
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840336500009Minder® AppP00001P000012025-12-01
00840336500023Minder® Wearable TemplateP2036355P20363552025-12-01
00840336500030Minder® Implant TemplateP2036377P20363772025-12-01
00840336500047Minder® Implant Bone Recess TemplateP2036363P20363632025-12-01
00840336500054Minder® Implant Electrode Array Exit Marking TemplateP2036360P20363602025-12-01
00840336500061Minder® Implant Recess GaugeP2036364P20363642025-12-01
00840336500078Minder® Surgical Instrument KitP2036354P20363542025-12-01
00840336500092Minder® WearableP2033684P20336842025-12-01
00840336500108Minder® Coil, 6cmP2033699P20336992025-12-01
00840336500115Minder® Coil, 8cmP2033688P20336882025-12-01
00840336500139Minder® Coil, 25cmP2033701P20337012025-12-01
00840336500146Minder® Magnet, 1/2MP2033707P20337072025-12-01
00840336500153Minder® Magnet, 1MP2033708P20337082025-12-01
00840336500160Minder® Magnet, 2MP2033730P20337302025-12-01
00840336500177Minder® Magnet, 3MP2033731P20337312025-12-01
00840336500184Minder® Magnet, 4MP2033718P20337182025-12-01
00840336500191Minder® Magnet, 5MP2033719P20337192025-12-01
00840336500207Minder® Magnet, 6MP20337212025-12-01
00840336500214Minder® Rechargeable BatteryP2033710P20337102025-12-01
00840336500221Minder® Y Battery ChargerP2033704P20337042025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840336500009Minder® AppEPIMINDER LIMITEDSEM2025-12-01
00840336500023Minder® Wearable TemplateEPIMINDER LIMITEDSEM2025-12-01
00840336500030Minder® Implant TemplateEPIMINDER LIMITEDSEM2025-12-01
00840336500047Minder® Implant Bone Recess TemplateEPIMINDER LIMITEDSEM2025-12-01
00840336500054Minder® Implant Electrode Array Exit Marking TemplateEPIMINDER LIMITEDSEM2025-12-01
00840336500061Minder® Implant Recess GaugeEPIMINDER LIMITEDSEM2025-12-01
00840336500078Minder® Surgical Instrument KitEPIMINDER LIMITEDSEM2025-12-01
00840336500092Minder® WearableEPIMINDER LIMITEDSEM2025-12-01
00840336500108Minder® Coil, 6cmEPIMINDER LIMITEDSEM2025-12-01
00840336500115Minder® Coil, 8cmEPIMINDER LIMITEDSEM2025-12-01
00840336500139Minder® Coil, 25cmEPIMINDER LIMITEDSEM2025-12-01
00840336500146Minder® Magnet, 1/2MEPIMINDER LIMITEDSEM2025-12-01
00840336500153Minder® Magnet, 1MEPIMINDER LIMITEDSEM2025-12-01
00840336500160Minder® Magnet, 2MEPIMINDER LIMITEDSEM2025-12-01
00840336500177Minder® Magnet, 3MEPIMINDER LIMITEDSEM2025-12-01
00840336500184Minder® Magnet, 4MEPIMINDER LIMITEDSEM2025-12-01
00840336500191Minder® Magnet, 5MEPIMINDER LIMITEDSEM2025-12-01
00840336500207Minder® Magnet, 6MEPIMINDER LIMITEDSEM2025-12-01
00840336500214Minder® Rechargeable BatteryEPIMINDER LIMITEDSEM2025-12-01
00840336500221Minder® Y Battery ChargerEPIMINDER LIMITEDSEM2025-12-01
00840336500238Minder® Earhook, SmallEPIMINDER LIMITEDSEM2025-12-01
00840336500245Minder® Earhook, MediumEPIMINDER LIMITEDSEM2025-12-01
00840336500252Minder® Earhook, LargeEPIMINDER LIMITEDSEM2025-12-01
00840336500269Minder® Koala ClipEPIMINDER LIMITEDSEM2025-12-01