Catalog Number

50-0048

Brand Name

Spacelabs Healthcare

Version/Model Number

TAY

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

-

Product Code

MWJ

Product Code Name

Electrocardiograph, ambulatory (without analysis)

Public Device Record Key

b542dfa3-fe72-4bab-9f0f-2ac16200d7d2

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 10, 2018

Package DI Number

30841522125601

Quantity per Package

20

Contains DI Package

10841522125461

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS