Catalog Number

-

Brand Name

HoMEDICS

Version/Model Number

BPA-740-CA

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

K093831,K093831

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

579cc62a-7923-4247-b0d9-60a9ac240951

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

January 06, 2017

Package DI Number

14719872483127

Quantity per Package

4

Contains DI Package

04719872483120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-