Catalog Number

0030403

Brand Name

ACE

Version/Model Number

0030403

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"

-

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

-

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

13ce303b-454e-4dbf-991a-63cdf3388822

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 20, 2017

Package DI Number

10614950008749

Quantity per Package

30

Contains DI Package

00614950008742

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box