Catalog Number

-

Brand Name

Electrocardiograph

Version/Model Number

SE-601A

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

-

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

80314dcb-a11b-4599-bcb7-1dd5f27dfa60

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

February 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-