Catalog Number

8888262121

Brand Name

Kangaroo

Version/Model Number

8888262121

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)

Yes

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

FPD

Product Code Name

TUBE, FEEDING

Public Device Record Key

c433da00-a3a0-48e4-8dd4-72a699d673a3

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 27, 2016

Package DI Number

20884521003894

Quantity per Package

50

Contains DI Package

30884521003891

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE