Catalog Number

PV512538BERN/A

Brand Name

Performa®

Version/Model Number

00884450362556

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

1f3242a2-3fa9-458e-8118-cc5217de2e52

Public Version Date

November 08, 2021

Public Version Number

2

DI Record Publish Date

June 11, 2018

Package DI Number

10884450362553

Quantity per Package

5

Contains DI Package

00884450362556

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-