Catalog Number

84065E

Brand Name

Kangaroo

Version/Model Number

84065E

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PNR

Product Code Name

Enteral Syringes with enteral specific connectors

Public Device Record Key

c8931eee-5fcf-4a41-8a57-256eb028479e

Public Version Date

March 29, 2021

Public Version Number

7

DI Record Publish Date

July 24, 2017

Package DI Number

20884521583082

Quantity per Package

30

Contains DI Package

10884521583085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE