Catalog Number

-

Brand Name

Blood Pressure Monitor LC-BP01

Version/Model Number

22~42

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

80cee8f2-b72e-4304-ac24-a198033e227b

Public Version Date

April 07, 2021

Public Version Number

1

DI Record Publish Date

March 30, 2021

Package DI Number

34897118930018

Quantity per Package

15

Contains DI Package

04897118930017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton