Catalog Number

CCST80X4

Brand Name

Spacelabs Healthcare

Version/Model Number

EVENTREC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 2019

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

-

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

DXH

Product Code Name

TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Public Device Record Key

09347809-d132-4554-9182-227ba8f35503

Public Version Date

January 31, 2019

Public Version Number

4

DI Record Publish Date

June 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-