Catalog Number

-

Brand Name

iHealth

Version/Model Number

BP5

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

252334e5-b815-4fcc-b4f5-c55a9f0fd6bd

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

10855111003047

Quantity per Package

2

Contains DI Package

00855111003040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-