Catalog Number

002-102738

Brand Name

Procure Blood Pressure Monitor, Digital, Auto Inflate w/ Batteries

Version/Model Number

002-102738

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

K150545,K150545

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

459926d0-9c04-4927-bc0e-27a2962e4a5e

Public Version Date

January 09, 2020

Public Version Number

1

DI Record Publish Date

January 01, 2020

Package DI Number

05060488571008

Quantity per Package

24

Contains DI Package

05060488570926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton