Catalog Number

-

Brand Name

QT ECG

Version/Model Number

QTERD100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

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

-

FDA Premarket Submission

K180157,K180157,K180157

Product Code

DXH

Product Code Name

Transmitters And Receivers, Electrocardiograph, Telephone

Public Device Record Key

d4e06a29-8084-473f-a3f9-4ece56c69e27

Public Version Date

March 10, 2021

Public Version Number

3

DI Record Publish Date

September 21, 2020

Package DI Number

04719872980698

Quantity per Package

1

Contains DI Package

04719872980414

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-