Catalog Number

460843

Brand Name

Kangaroo

Version/Model Number

460843

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

274b611b-ea86-4815-af20-cfb5b6e476ac

Public Version Date

October 12, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521165141

Quantity per Package

5

Contains DI Package

10884521165144

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE