Catalog Number

-

Brand Name

HoMEDICS

Version/Model Number

BPA-730-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

d6267e87-9c88-44fa-ad4a-49e160cf0d7d

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

14719872483110

Quantity per Package

4

Contains DI Package

04719872483113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-