Catalog Number

-

Brand Name

HoMEDICS

Version/Model Number

BPA-110

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

K092161,K092161

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

862f7782-5ec4-4be3-8f33-b02f9996d9ff

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

14719872483158

Quantity per Package

4

Contains DI Package

04719872483151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-