Catalog Number

PV415038U1

Brand Name

Performa®

Version/Model Number

00884450407417

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

Yes

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

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

4ddd6c27-be59-4a35-8a54-1c9bf2ccb171

Public Version Date

November 08, 2021

Public Version Number

2

DI Record Publish Date

October 23, 2019

Package DI Number

10884450407414

Quantity per Package

5

Contains DI Package

00884450407417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-