Catalog Number

-

Brand Name

Sunbeam

Version/Model Number

FT-B06W-V

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150430,K150430

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

e5d2eede-af5b-4998-8729-25ee3be2d1f4

Public Version Date

July 09, 2021

Public Version Number

1

DI Record Publish Date

July 01, 2021

Package DI Number

30694501169819

Quantity per Package

24

Contains DI Package

00694501169818

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case