Catalog Number

8884761100

Brand Name

Kangaroo

Version/Model Number

8884761100

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

67509f53-8228-46a2-944e-16925c8368e1

Public Version Date

November 27, 2020

Public Version Number

1

DI Record Publish Date

November 19, 2020

Package DI Number

50192253012369

Quantity per Package

40

Contains DI Package

10192253012361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE