Catalog Number

8884741212

Brand Name

Kangaroo

Version/Model Number

8884741212

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

e3c83ece-bca8-438e-9c85-6abd2a558381

Public Version Date

March 25, 2019

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521011509

Quantity per Package

30

Contains DI Package

10884521011502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE