Catalog Number

-

Brand Name

HoMedics

Version/Model Number

BPW-O300

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

ab8ce4a6-629a-43fd-85a6-ff287fb249ee

Public Version Date

September 28, 2020

Public Version Number

3

DI Record Publish Date

June 22, 2018

Package DI Number

14719872480218

Quantity per Package

48

Contains DI Package

04719872480211

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-