Catalog Number

461800E

Brand Name

Kangaroo

Version/Model Number

461800E

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

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Public Device Record Key

5a3a15b6-7b28-403d-ba3f-63c9e7a063b0

Public Version Date

November 16, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521547176

Quantity per Package

10

Contains DI Package

10884521547179

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE