Catalog Number

53035KA2/B

Brand Name

Impress®

Version/Model Number

00884450661475

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

3219f9f5-6104-4c68-ac8f-d938fd88bf41

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

10884450661472

Quantity per Package

5

Contains DI Package

00884450661475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-