Catalog Number

FT-B05W

Brand Name

Advocate Blood Pressure Monitor Non-Speaking Wrist

Version/Model Number

FT-B05W

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

K150430,K150430,K150430

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

48859509-61d5-463d-b83d-586ddf7f7359

Public Version Date

April 23, 2021

Public Version Number

7

DI Record Publish Date

April 17, 2017

Package DI Number

10852982006405

Quantity per Package

48

Contains DI Package

00852982006408

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

FT-B05W-CASE