Catalog Number

-

Brand Name

Beat

Version/Model Number

B02T

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172171,K172171

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

c7e22b97-fb93-4a20-9fd3-61e0443349c2

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

October 01, 2020

Package DI Number

10863398000284

Quantity per Package

20

Contains DI Package

00863398000287

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton