Catalog Number

674626

Brand Name

Kangaroo

Version/Model Number

674626

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

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

7c043fa3-930e-4a24-b194-4bae4ce813bb

Public Version Date

January 07, 2020

Public Version Number

1

DI Record Publish Date

December 30, 2019

Package DI Number

20884521064840

Quantity per Package

30

Contains DI Package

10884521064843

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE