Catalog Number

8884711006E

Brand Name

Kangaroo

Version/Model Number

8884711006E

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

e27e261f-5231-45e7-9bc7-7db70c946f1d

Public Version Date

March 25, 2019

Public Version Number

7

DI Record Publish Date

July 04, 2017

Package DI Number

20884521582900

Quantity per Package

10

Contains DI Package

10884521582903

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE