Catalog Number

-

Brand Name

HoMedics

Version/Model Number

BPW-715

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

b4f3474c-927c-4d77-9ea0-1ac6ebb8f334

Public Version Date

September 28, 2020

Public Version Number

3

DI Record Publish Date

December 18, 2018

Package DI Number

14719872480225

Quantity per Package

12

Contains DI Package

04719872480228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-