Catalog Number

-

Brand Name

LUMEX

Version/Model Number

2100A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FOX

Product Code Name

Stand, Infusion

Public Device Record Key

b921183c-e0f8-4e4f-a731-eab25183b29a

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Package DI Number

M3682100A2

Quantity per Package

3

Contains DI Package

M3682100A1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box