Catalog Number

P548380

Brand Name

Pro Advantage

Version/Model Number

P548380

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

6fb71892-c80f-40cc-9a3e-6bf003e8147d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 13, 2017

Package DI Number

M200P5483805

Quantity per Package

12

Contains DI Package

M220P5483803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case