Catalog Number

5-058-00

Brand Name

Commwell

Version/Model Number

ECG Mgmt Sys with ECG Analysis

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

K103791

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

7bc8db0b-621a-452a-a48c-62ea8dac9a12

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

January 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-