Catalog Number

-

Brand Name

Ozeri

Version/Model Number

BP8H

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123600,K123600,K123600

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

99d0c2b6-d51c-4f26-b6a5-9f8f08fbed0a

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

May 15, 2017

Package DI Number

20815817012450

Quantity per Package

10

Contains DI Package

10815817012453

Package Discontinue Date

May 15, 2017

Package Status

Not in Commercial Distribution

Package Type

Carton box