Catalog Number

-

Brand Name

AMC

Version/Model Number

KT-EDR1292

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

b85e81bd-1af1-4c72-8fb4-8cc199d3f066

Public Version Date

February 03, 2021

Public Version Number

1

DI Record Publish Date

January 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-