Catalog Number

-

Brand Name

iHealth

Version/Model Number

BP5S

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

K171062,K171062

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

75f7c550-c942-4beb-b44b-2f82a891a710

Public Version Date

September 21, 2022

Public Version Number

1

DI Record Publish Date

September 13, 2022

Package DI Number

10850044118028

Quantity per Package

24

Contains DI Package

00850044118021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-