Catalog Number

H-FMSI- 826

Brand Name

FLORIDA MEDICAL SALES INC.

Version/Model Number

FMSI-826

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

b9b0b62a-8d1d-4235-bb41-d3c37f84115a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 22, 2016

Package DI Number

10857444006054

Quantity per Package

20

Contains DI Package

00857444006057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE