Catalog Number

P549515

Brand Name

Pro Advantage

Version/Model Number

P549515

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

7ccee353-aa4c-4d5c-99e4-c776b5f8ba01

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

M220P5495155

Quantity per Package

15

Contains DI Package

M220P5495153

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case