Catalog Number

-

Brand Name

Carewell

Version/Model Number

ECG-1112D

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

K113485

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

dfc9463d-0db0-4a0b-b1c3-4910208d5742

Public Version Date

November 08, 2021

Public Version Number

4

DI Record Publish Date

January 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-