Catalog Number

460855E

Brand Name

Kangaroo

Version/Model Number

460855E

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

4d524944-7974-4a8f-b5f7-a4bc0955e201

Public Version Date

June 17, 2019

Public Version Number

8

DI Record Publish Date

May 28, 2017

Package DI Number

10884521706101

Quantity per Package

5

Contains DI Package

20884521706108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE