Catalog Number

700-0367-00

Brand Name

Spacelabs Healthcare

Version/Model Number

ARIA; 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

-

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

1b01a4eb-6d7c-4331-ac36-409d8aff4274

Public Version Date

March 29, 2019

Public Version Number

1

DI Record Publish Date

March 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-