FDA.reportPublic FDA data

MediMax Tech

Primary DI
00817325022347
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
MXF55RW-5 ECG
Device description
MXF55RW-5 ECG: PE Foam, Wet Gel, Adult Round 55mm ECG Electrode, 5pcs/Pack, 100pcs/Box, 1000pcs/Master Case
Published
2016-08-18
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
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083148000TELECTRODE WET GEL ECG ELECTRODEBio Protech, Inc.2008-11-07DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817325022344PackageGS120In Commercial Distribution
20817325022341PackageGS110In Commercial Distribution
00817325022347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081732502234410817325022344
2081732502234120817325022341
00817325022347008173250223478173250223470817325022347

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use 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
00817325020398MediMax TechMF2409 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281174Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281501Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281525Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281532Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281549Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281587Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281600Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282829Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282881Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282898Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282904Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282911Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282942Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282959Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282966Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282980Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283017Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283024Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283048Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283055Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283062Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283086Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20