Catalog Number

-

Brand Name

HOMEDICS

Version/Model Number

BPA-960BT

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

K200521,K200521

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

6625151a-cafb-43cb-961f-20aa43d35200

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

May 01, 2021

Package DI Number

10031262101560

Quantity per Package

4

Contains DI Package

00031262101563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case