Catalog Number

-

Brand Name

Manual Blood Pressure Monitor

Version/Model Number

HEM-432CN2

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

K903133,K903133

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

19b0f592-b2cb-4455-abf9-21a18fc4328c

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10073796043220

Quantity per Package

12

Contains DI Package

00073796043223

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case