Catalog Number

-

Brand Name

HOMEDICS

Version/Model Number

BPA-960BT-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

K200521,K200521

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

82c4500f-9ec0-4754-afcd-61c72ce0203d

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Package DI Number

10031262105025

Quantity per Package

6

Contains DI Package

00031262105028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-