Catalog Number

-

Brand Name

N/A

Version/Model Number

PP-BPCUFF17             

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

K092161,K092161

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

b6f242e3-0775-4f08-898e-62905b12eeb5

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

November 03, 2016

Package DI Number

14719872489013

Quantity per Package

50

Contains DI Package

04719872489016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-