Catalog Number

-

Brand Name

FDK

Version/Model Number

FT-B12W-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,K150430

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

459d69bc-3b27-4c4f-be03-2db25f762cc3

Public Version Date

September 28, 2020

Public Version Number

6

DI Record Publish Date

December 21, 2016

Package DI Number

10867464000215

Quantity per Package

48

Contains DI Package

00867464000218

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case