Catalog Number

-

Brand Name

HOMEDICS

Version/Model Number

BPW-930BT-WT

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

K160557,K160557

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

0cd07549-7d72-4407-baa6-6c3ea67d52f8

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Package DI Number

10031262105032

Quantity per Package

12

Contains DI Package

00031262105035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-