Catalog Number

PV515038U1

Brand Name

Performa®

Version/Model Number

00884450407455

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

6d78d3da-ae86-47d8-80ed-f6a0d3f3ab4e

Public Version Date

November 08, 2021

Public Version Number

2

DI Record Publish Date

February 03, 2020

Package DI Number

10884450407452

Quantity per Package

5

Contains DI Package

00884450407455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-