Catalog Number

MDSM611LIMB

Brand Name

Medline

Version/Model Number

MDSM611LIMB

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

K053011,K053011,K053011

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

ffe5ef19-f69f-48d2-b4a0-c0b29210d266

Public Version Date

December 18, 2020

Public Version Number

1

DI Record Publish Date

December 10, 2020

Package DI Number

30888277688456

Quantity per Package

300

Contains DI Package

20888277688459

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE