Catalog Number

H-FMSI- 836

Brand Name

Florida Medical Sales, Inc.

Version/Model Number

FMSI-836

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)

-

Over the Counter (OTC)

Yes

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

209dcf68-ca71-481c-8ea2-a17a39d73d52

Public Version Date

August 05, 2020

Public Version Number

1

DI Record Publish Date

July 28, 2020

Package DI Number

10857444006092

Quantity per Package

20

Contains DI Package

00857444006095

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE