Catalog Number

-

Brand Name

HoMEDICS

Version/Model Number

BPA-040

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

K042853,K042853

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

b38edf21-d824-455f-888d-83fff2250e43

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

14719872483141

Quantity per Package

4

Contains DI Package

04719872483144

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-