Catalog Number

555500R401

Brand Name

INFINITI

Version/Model Number

555500R401

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K970854,K970854

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

9abcc215-f22d-43c7-9724-70d5b90c1125

Public Version Date

August 12, 2022

Public Version Number

4

DI Record Publish Date

October 08, 2018

Package DI Number

20705032079218

Quantity per Package

5

Contains DI Package

10705032079211

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX