Catalog Number

8884704506

Brand Name

Kangaroo

Version/Model Number

8884704506

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"

Yes

For Single-Use

-

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

c3f4e3a8-9e6e-49c5-9a29-bafb49917da9

Public Version Date

December 17, 2019

Public Version Number

1

DI Record Publish Date

December 09, 2019

Package DI Number

20884521028378

Quantity per Package

30

Contains DI Package

10884521028371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE