Catalog Number

-

Brand Name

HoMEDICS

Version/Model Number

BPW-060

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

K050249,K050249

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

856c88cc-f480-48af-8228-4cfe418d047d

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

14719872480133

Quantity per Package

6

Contains DI Package

04719872480136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-