Catalog Number

-

Brand Name

AMC

Version/Model Number

KT-ELX1765

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 2021

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

ea9d932e-bfeb-4744-9492-91f4e782a4cf

Public Version Date

March 03, 2021

Public Version Number

2

DI Record Publish Date

January 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-