Catalog Number

-

Brand Name

AMC

Version/Model Number

KT-EDR3986

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"

Yes

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

K992524

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

0aeb746c-64fd-4c98-ae1c-11ad42e123dd

Public Version Date

March 11, 2021

Public Version Number

1

DI Record Publish Date

March 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-