Catalog Number

-

Brand Name

Blood Pressure Monitor CH-657

Version/Model Number

CH657V1

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

64ac10ac-bc18-468f-a17f-3d803d9f8b65

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

30845717004047

Quantity per Package

3

Contains DI Package

00845717004046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton