Catalog Number

AMG-503-LG

Brand Name

Ameritus

Version/Model Number

AMG-503-LG

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"

Yes

For Single-Use

Yes

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

K050443,K050443

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

75f6924b-baa4-4a74-9bb9-a5a75eb53b20

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Package DI Number

20817522010356

Quantity per Package

50

Contains DI Package

10817522010359

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box