Catalog Number

015-0721-01

Brand Name

SPACELABS HEALTHCARE

Version/Model Number

90200

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

K050225,K050225,K050225

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

b99cef98-8d6e-4a5e-bd21-bcf574d00714

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 12, 2017

Package DI Number

50841522102491

Quantity per Package

20

Contains DI Package

10841522102493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case