Catalog Number

-

Brand Name

HoMedics

Version/Model Number

BPA-O200

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

K130563,K130563

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

4ca554fc-c0dd-4eca-bb3f-eef2ff7d7c5f

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

June 22, 2018

Package DI Number

14719872483226

Quantity per Package

12

Contains DI Package

04719872483229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-