Catalog Number

-

Brand Name

MediMax Tech

Version/Model Number

MXF47T-50

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K020003,K020003,K020003

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

4ef17117-fe8a-474a-8fcc-0d9c2f67b4c1

Public Version Date

November 12, 2018

Public Version Number

1

DI Record Publish Date

October 10, 2018

Package DI Number

20817325023393

Quantity per Package

4

Contains DI Package

10817325023396

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case