Catalog Number

RX93030-009

Brand Name

A.C.T. (American Cardiac Telemetry)

Version/Model Number

Sirona

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

K112601

Product Code

MWJ

Product Code Name

Electrocardiograph,Ambulatory(Without Analysis)

Public Device Record Key

3488e3ba-5e7b-428f-9121-b581792e8f92

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

March 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-