Catalog Number

MDSM611300

Brand Name

Medline

Version/Model Number

MDSM611300

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"

Yes

For Single-Use

Yes

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

-

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

8ce96112-e383-4499-aeef-febaac618a6f

Public Version Date

January 12, 2021

Public Version Number

1

DI Record Publish Date

January 04, 2021

Package DI Number

30888277399383

Quantity per Package

100

Contains DI Package

20888277399386

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX