Catalog Number

ICU2000-A

Brand Name

ICU

Version/Model Number

ICU2000-A

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)

-

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

d77ae003-3f3e-46f4-8ec9-bf789dbb8f8b

Public Version Date

March 28, 2022

Public Version Number

1

DI Record Publish Date

March 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-