Catalog Number

-

Brand Name

N/A

Version/Model Number

PP-BPCUFF30

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

K142968,K142968

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

9b3b15b3-959e-4ca6-add8-1f91ba6c3b4a

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

August 22, 2017

Package DI Number

14719872489082

Quantity per Package

50

Contains DI Package

04719872489085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-