Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS9100-5

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

K041954,K041954,K041954,K041954

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

73972937-8ad6-498c-b992-f52d230e5cae

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 13, 2017

Package DI Number

10849027002645

Quantity per Package

2000

Contains DI Package

00849027002648

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case