Catalog Number

IMS-0600

Brand Name

Ivenix Infusion System

Version/Model Number

3.0.0

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

-

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

PHC

Product Code Name

Infusion Safety Management Software

Public Device Record Key

1280293b-b0ad-4a82-ab73-b7e74c9efc61

Public Version Date

September 07, 2022

Public Version Number

3

DI Record Publish Date

June 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-