Catalog Number

60ES

Brand Name

Kangaroo

Version/Model Number

60ES

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

d1d06149-1f3a-480c-a65f-ea7c3579a7fd

Public Version Date

November 02, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

10884521143913

Quantity per Package

50

Contains DI Package

20884521143910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE