Catalog Number

-

Brand Name

N/A

Version/Model Number

PP-BPCUFF32

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

K153214,K153214

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

f4160dc7-c369-43ea-b589-0c82c43ac78e

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

April 07, 2017

Package DI Number

14719872489105

Quantity per Package

40

Contains DI Package

04719872489108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-