Catalog Number

PV413538BERN

Brand Name

Performa®

Version/Model Number

00884450407431

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

6a1f50bb-d580-42a3-b203-4a458d400a56

Public Version Date

November 08, 2021

Public Version Number

2

DI Record Publish Date

May 01, 2019

Package DI Number

10884450407438

Quantity per Package

5

Contains DI Package

00884450407431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-