Catalog Number

461000E

Brand Name

Kangaroo

Version/Model Number

461000E

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

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

KYX

Product Code Name

DISPENSER, LIQUID MEDICATION

Public Device Record Key

357b6e01-2f58-419a-89a4-f5b9888bb0b3

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

June 28, 2018

Package DI Number

20884521581897

Quantity per Package

100

Contains DI Package

10884521581890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE