Catalog Number

775759

Brand Name

Kangaroo

Version/Model Number

775759

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

K945964,K945964

Product Code

LZH

Product Code Name

PUMP, INFUSION, ENTERAL

Public Device Record Key

78baa6ba-af3e-4590-803d-d8304708778f

Public Version Date

February 15, 2019

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884521155732

Quantity per Package

30

Contains DI Package

20884521155739

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE