Catalog Number

5500

Brand Name

TRACE 1

Version/Model Number

5500

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

K022909,K022909,K022909,K022909

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

ae34025d-53f4-4c2c-805a-fe2770b7c088

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 17, 2017

Package DI Number

20853512006428

Quantity per Package

10

Contains DI Package

10853512006421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bx