Catalog Number

-

Brand Name

N/A

Version/Model Number

PP-BPCUFF22    

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

K042853,K042853

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

f75af820-f9e0-4c0e-b632-06768301c090

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

April 06, 2017

Package DI Number

14719872489044

Quantity per Package

40

Contains DI Package

04719872489047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-