FDA.reportPublic FDA data

MediMax Tech

Primary DI
00817325020398
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
MF2409 Surface Electrodes
Device description
MF2409: Ring, Surface EMG Electrodes, Pet Film, 8x107mm, Hydrogel
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153019000Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesBio Protech, Inc.2016-03-21GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817325020395PackageGS110In Commercial Distribution
20817325020392PackageGS110In Commercial Distribution
00817325020398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081732502039510817325020395
2081732502039220817325020392
00817325020398008173250203988173250203980817325020398

GMDN Terms#

Term, Definition table
TermDefinition
Neuromuscular transmission motion sensorA device intended to be placed on the thumb and index finger of a patient to detect movements and convert them into electrical neuromuscular transmission (NMT) signals during nerve stimulation. The device, also known as a mechanosensor, is a piezoelectric sensor that functions with an NMT sensor cable and skin surface NMT electrodes to transmit electrical signals to a patient monitoring module dedicated to the monitoring of patient relaxation to determine level of neuromuscular block. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
855-633-4629Malorie.c@medimaxtech.com

Regulatory Flags#

DUNS number
927071162
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817325025003iVisionOCV-20-S12026-04-30
00817325025010iChopperIC-27G2026-04-30
00817325023764MediMax TechPSF22020-09-24
00817325023771MediMax TechASF32020-09-24
00817325023788MediMax TechASFN32020-09-24
00817325023795MediMax TechASFT032020-09-24
00817325023801MediMax TechTS32020-11-16
00817325023818MediMax TechTV32020-11-16
00817325023825MediMax TechTO3 2020-11-16
00817325026574MediMaxTech Inc.MSH22M2024-03-25
10817325023808MediMax TechTS32020-11-16
10817325023815MediMax TechTV32020-11-16
10817325023822MediMax TechTO3 2020-11-16
10817325026571MediMaxTech Inc.MSH22M2024-03-25
00817325020381MediMax TechNCS-SG15 Surface Electrodes2016-08-19
00817325020350MediMax TechSG15R Surface Electrodes2016-08-19
00817325020367MediMax TechSG15G Surface Electrodes2016-08-19
00817325022729MediMax TechSG15G Surface Electrodes- 5 pc Sample Pack2017-01-18
00817325020695MediMax TechInnostim Tens 1k Unit2016-08-02
00817325020725MediMax TechInnostim EMS 2k Unit2016-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08