Catalog Number

-

Brand Name

ECG

Version/Model Number

4130

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K082077,K082077

Product Code

DXH

Product Code Name

TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Public Device Record Key

b29628d2-9c5d-402d-8657-2b627ed966d2

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 09, 2021

Package DI Number

05099169413337

Quantity per Package

1

Contains DI Package

15099169413334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-