Catalog Number

741623

Brand Name

Kangaroo

Version/Model Number

741623

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)

-

Over the Counter (OTC)

Yes

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

89d9bf91-7912-4e79-9bf9-d321a79875d8

Public Version Date

April 20, 2020

Public Version Number

9

DI Record Publish Date

September 24, 2016

Package DI Number

20884521067230

Quantity per Package

30

Contains DI Package

10884521067233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE