Catalog Number

510038BER/B

Brand Name

Impress®

Version/Model Number

00884450661437

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

d1cd92d8-2074-4a5b-a17b-5badf0284d1a

Public Version Date

August 19, 2022

Public Version Number

1

DI Record Publish Date

August 11, 2022

Package DI Number

10884450661434

Quantity per Package

5

Contains DI Package

00884450661437

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-