Catalog Number

-

Brand Name

N/A

Version/Model Number

PP-BPCUFF34

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

K161156,K161156

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

866aef05-a850-4861-b697-429a428a6224

Public Version Date

October 14, 2021

Public Version Number

1

DI Record Publish Date

October 06, 2021

Package DI Number

14719872489174

Quantity per Package

40

Contains DI Package

04719872489177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-