Catalog Number

-

Brand Name

AWARE DART

Version/Model Number

1.1

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"

-

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

K143372

Product Code

MWI

Product Code Name

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Public Device Record Key

5b69457d-301c-422e-852e-965e1208ab21

Public Version Date

October 24, 2022

Public Version Number

8

DI Record Publish Date

July 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-