Catalog Number

730

Brand Name

S&W

Version/Model Number

T-604

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

K024264,K024264,K024264,K024264

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

0fea9cf6-b029-42d7-93a9-dcd17e695b0e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

30854661006380

Quantity per Package

4

Contains DI Package

20854661006383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case