Catalog Number

512538BER/B

Brand Name

Impress®

Version/Model Number

00884450653746

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

52a775a1-79b3-40c6-8cfd-29929e188ee1

Public Version Date

September 15, 2022

Public Version Number

1

DI Record Publish Date

September 07, 2022

Package DI Number

10884450653743

Quantity per Package

5

Contains DI Package

00884450653746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-