Catalog Number

SET-0034-01

Brand Name

Ivenix Infusion System

Version/Model Number

SET-0034-01

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

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

e64b6744-a69f-4200-b1a5-e3a6ca49a1f8

Public Version Date

September 07, 2022

Public Version Number

3

DI Record Publish Date

March 24, 2022

Package DI Number

10811505030235

Quantity per Package

25

Contains DI Package

00811505030238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper