Catalog Number

-

Brand Name

FDK

Version/Model Number

FT-C15Y

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

a5d429e8-0a08-4f60-afd9-fa4b2c389c88

Public Version Date

September 28, 2020

Public Version Number

6

DI Record Publish Date

November 03, 2017

Package DI Number

00859020006246

Quantity per Package

24

Contains DI Package

00859020006222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case (24)