MediMax Tech

GUDID 20817325021481

MXF43R-30 ECG: PE Foam, Adult, Round 43mm, ECG Electrode, 30pcs/Pack, 600pcs/Box, 6000pcs/Master Case

MEDIMAX TECH INC.

Electrocardiographic electrode, single-use
Primary Device ID20817325021481
NIH Device Record Key443c3243-ee65-4618-b917-0fb88a66ebf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMediMax Tech
Version Model NumberMXF43R-30 ECG
Company DUNS927071162
Company NameMEDIMAX TECH INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-633-4629
EmailMalorie.c@medimaxtech.com
Phone855-633-4629
EmailMalorie.c@medimaxtech.com
Phone855-633-4629
EmailMalorie.c@medimaxtech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817325021487 [Primary]
GS110817325021484 [Package]
Contains: 00817325021487
Package: Inner Box [20 Units]
In Commercial Distribution
GS120817325021481 [Package]
Contains: 10817325021484
Package: Master Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-19

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