Catalog Number

LVP-SW-0001

Brand Name

Ivenix, Inc.

Version/Model Number

2.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 03, 2021

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

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

88c48a89-ab6f-46b9-b78c-5bb33321968d

Public Version Date

September 07, 2022

Public Version Number

6

DI Record Publish Date

August 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-