Catalog Number

46538KA2/B

Brand Name

Impress®

Version/Model Number

00884450668139

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

feb5a020-d0b1-4a3a-af52-daa4d8fc2b2b

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Package DI Number

10884450668136

Quantity per Package

5

Contains DI Package

00884450668139

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-